According to W.H.O-C.C.I.D.M, the science and activities relating to detecting, assessing,

understanding, preventing, and reporting adverse effects or any other drug-related problem.

a. An identifiable reporter

b. An identifiable patient

c. A suspect product

d. An adverse drug event.

Any untoward medical occurrence that may present during treatment with a pharmaceutical

product but which does not necessarily have a causal relationship with this treatment.

If an event is associated with any one of the following, it is considered to be serious.

a. Death

b. Life-threatening

c. Hospitalization or prolongation of hospitalization.

d. Congenital anomaly

e. Disability

f. Medically significant.

USA: United States Food and Drug Administration (USFDA).

UK: European Medicines Agency (EMEA).

Japan: Ministry of Health, Labour and Welfare (MHLW).

India: IDA Indian Drug Administration, previously known as Central Drugs Standard

Control Organization (CDSCO).

A case is considered to be medically confirmed if it contains at least one event confirmed or

reported by an HCP (Health Care Professional).

Note: HCP can be a physician, nurse, pharmacist, coroner, or psychologist (only in

Germany).

Causality is the relationship between a set of factors. In Pharmacovigilance, causality is the

relationship between the suspect product and the adverse drug event.

∙Is there a convincing relationship between the drug and the event?

∙Did the drug actually cause the event?

Patient demographics: Age, gender, and race.

Suspect product details: Drug, dose, dosage form, therapy dates, therapy duration and

indication. Adverse event details: Event, event onset date, seriousness criterion, event end

date and latency.

A narrative should consist of precise and concise information about the source of the report,

patient demographics, patient’s medical history, concomitant medications, suspect product

details and adverse event details in an orderly manner.

System Organ Class (SOC)

High-Level Group Term (HLGT)

High-Level Term (HLT)

Preferred Term (PT)

Lower-Level Term (LLT).

∙E2a: E2a guidelines give standard definitions and terminology for crucial aspects of

clinical safety reporting. It also guides mechanisms for handling expedited (rapid)

reporting of adverse drug reactions in the investigational phase of drug development.

∙E2b: E2b guidelines for maintaining clinical safety data management and information

about the data elements to transmit Individual Case Safety Reports.

∙E2c: E2b guidelines for maintaining clinical safety data management and information

about the Periodic Safety Update Reports for marketed drugs

This program will increase the knowledge and importance of Pharmacovigilance in the drug

discovery process and Clinical Research. Pharmacovigilance is becoming an essential part of

drug development as it deals with the patient’s safety & efficacy of the drug, resulting in new

job avenues. The participants, after the completion of this, would have new economic

pursuits as Pharmacovigilance's potential opportunities & growth prospects are enormous.

Pharmacovigilance Programme of India (PVPI) - launched in July 2010.

Goal: “To ensure the benefits of the use of medicine. Safeguard the health of the Indian

population.”

Manage and relay drug safety information, maintain current knowledge of global drug safety

regulations, summarise clinical safety data, participate in meetings with potential and actual

study sponsors, write narratives with medical input from a physician, report SADRs to the

Regulatory Authorities, participate in the training of operational staff on drug safety issues,

quality control work of other staff in the department, take on any other task as assigned by the

manager or Medical Director within the capabilities of the Drug Safety Associate.

Evidence - medicine-related problems

Public confidence

Identification of risk factors

Quantifying risks

 Understanding the concepts of ADR, Medical Errors, Public Health Significance,

Regulatory Interventions, and ADR Monitoring schemes.

The science and activities relating to the detection, assessment, understanding and prevention

of adverse effects or any other drug-related problems.

Two types. 1. Active PV and 2. Passive PV

Active PV: Active (or proactive) safety surveillance means active measures are taken to

detect adverse events. This is managed by active follow-up after treatment, and the events

may be detected by asking patients directly or screening patient records. The most

comprehensive method is cohort event monitoring (CEM).

Passive PV: Passive surveillance means that no active measures are taken to look for adverse

effects other than the encouragement of health professionals and others to report safety

concerns. Reporting is dependent on the initiative and motivation of the potential reporters.

This is the most common form of pharmacovigilance. It is commonly called “spontaneous” or

“voluntary” reporting.

Safety reporting due dates are 7 days for IND Reporting and 15 days for NDA Reporting.

Data assessments are:

∙Individual case report assessment

∙Aggregated assessment and interpretation

∙Signal detection

∙Interactions and risk factors

∙Serial study

∙Frequency Estimation

∙Rapid identification of events that are likely to affect adherence to treatment and

determination of their rates and identification of the risk factors that make these events

more likely to reduce their occurrence;

∙Identification of signals (i.e., possible causal relationships between an adverse event and a

medicine; see Glossary) of ADRs of concern following the introduction of a new drug or

drug combination;

∙Assessment of signals to evaluate causality, clinical relevance, frequency, and distribution

of ADRs in particular population groups;

calculation of rates of events so that:

— risk can be measured;

— the safety of different medicines can be compared and informed choices made;

— risk factors can be clearly identified;

∙ Contribution to the assessment of benefit, harm, effectiveness, and risk of medicines,

leading to the prevention of harm and maximization of benefit;

∙Appropriate response or action in terms of drug registration, drug use and/or training and

education for health professionals and the public;

∙Measurement and evaluation of the outcome of the response or action taken (e.g.

reduction in risk, improved medicine use, or improved outcome for patients experiencing

a particular ADR);

∙Timely communication with and recommendations to authorities and the public; and

∙Feedback to the clinicians who provided the information.

The PvC of an individual country is responsible for meeting the requirements for

pharmacovigilance of all medicines. It is a centre of expertise for the art and science of

monitoring and analysing ADRs and using the information analysed to benefit patients.

National and regional PvCs should be set up with the approval or involvement of the

authority responsible for regulating medicines (“regulatory authority”). The centre may

function within the regulatory authority, a hospital, an academic institution, or an independent

facility such as a trust or foundation.

Spontaneous (or voluntary) reporting means that no active measures are taken to look for

adverse effects other than the encouragement of health professionals and others to report

safety concerns. Reporting is entirely dependent on the initiative and motivation of the

potential reporters. This is the most common form of pharmacovigilance, sometimes termed

passive reporting. In some countries, this form of reporting is mandatory. Clinicians,

pharmacists, and community members should be trained on how, when, what and where to

report.

∙Telephone

∙Fax

∙E-mail

∙Internet

The WHO Drug Dictionary (DD), MedDRA and the WHO Adverse Reactions Terminology

(WHO-ART).

WHODD= used for drug coding.

MedDRA, WHO-ART = coding of events.

CemFlow is a tool maintained by the UMC for database management in cohort event

monitoring (CEM). It is web-based, and the fields match the questionnaire data elements.

There are screens for patient demographics, treatment initiation, treatment review and

assessment of events. CemFlow is a tool for data entry into an online database maintained by

the UMC (Uppsala Monitoring Centre) for CEM. CemFlow provides for the entry of cohort

data as well as events.

∙Patient details (Name, Address, Sex, Date of birth, Weight, and height).

∙Patient's medical history of significance.

∙Details of medicines (this may be the brand or generic name, preferably brand) and

formulation, mode of administration (e.g. oral, rectal, or injection), Indication(s) for use,

dose).

∙Reaction details (Date of onset, outcome: resolved, resolving, no change, disabling,

worsening, death (with date), or congenital anomaly, Effect of rechallenge).

∙Reporter details

∙Date and place of report

Not severe, mild, moderate, or severe.

Related: Certain, possible, probable, likely.

Not related: Unlikely, Unclassified (or conditional), Unassessable.

Pregnancy.

Overdose (>MTD)

Off label use

Medication error

Lack of efficacy.

Patients may be more susceptible to particular ADRs if they also have other health problems,

either because of the concomitant condition or from the interaction of the medicines used to

treat the other condition(s).

Reported information on a possible causal relationship between an adverse event and a drug,

the relationship being unknown or incompletely documented previously. Usually, more than a

single report is required to generate a signal, depending upon the seriousness of the event and

the quality of the information. The publication of a signal usually implies the need for some

review or action.

There are four methods for identifying signals:

1. Clinical assessment of individual events

2. Clinical review of collated events

3. Record linkage

4. Automated signal detection.

∙ADRs- adverse reactions to medicines (adverse drug reactions)

ART- antiretroviral therapy

∙ARV- antiretroviral

∙ATC- Anatomic Therapeutic Chemical (Classification for medicines)

∙BCPNN- Bayesian Confidence Propagating Neural Network

∙CEM- cohort event monitoring

∙CemFlow- Cohort Event Monitoring data entry and analytical tool

∙DD (WHO)- Drug Dictionary

∙ICD 10- WHO International Classification of Diseases version 10

∙IMAI- integrated management of adolescent and adult illness

∙ICSR- individual case safety report(s)

∙MedDRA- Medical Dictionary for drug regulatory activities

∙OI- opportunistic infection

∙IMMP- (The New Zealand) Intensive Medicines Monitoring Programme

∙PEM- prescription event monitoring

∙PvC- Pharmacovigilance Centre

∙VigiBase- WHO database of individual case safety (ADR) reports (ICSR)

∙VigiFlow- spontaneous reporting data entry and analytical tool

∙VigiMine- data mining tool available as part of VigiSearch

∙VigiSearch- search tool for searching the VigiBase database

∙WHO- World Health Organization

∙WHO-ART WHO adverse reactions terminology.

∙SUSAR- Suspected Unexpected Serious Adverse Reaction

∙SAE- Serious Adverse Event

∙CIOMS- Council for International Organizations of Medical Sciences

∙ADE- Adverse Drug Event

∙SSAR- Suspected Serious Adverse Reaction

∙SOC- system organ class

∙SOP- standard operating procedure

∙UMC- the Uppsala Monitoring Centre

∙ADR- Adverse Drug Reaction

∙ICSR- Individual Case Safety Report

∙PSUR- Periodic Safety Update Report

∙ICH- The International Conference on Harmonisation of Technical Requirements for

Registration of Pharmaceuticals for Human Use

∙HIPAA- Health Insurance Portability and Accountability Act

∙ESTRI- Electronic Standards for the Transfer of Regulatory Information

∙IBD- International Birth Date

∙ATC- Anatomical Therapeutic Chemical (ATC) Classification.

The types of outcomes to be recorded are as follows, along with codes that can be used to

simplify recording:

R1 resolved;

R2 resolving;

RS resolved with sequelae;

NR not resolved.

The point at which a drug is again given to a patient after its previous withdrawal - also see de-challenge.

The withdrawal of a drug from a patient; the point at which the continuity,

reduction or disappearance of adverse effects may be observed.

This is an important international society. Their website gives information about meetings

and training courses.

Absolute risk

Risk in a population of exposed persons: the probability of an event affecting members of a

particular population (e.g. 1 in 1,000). Absolute risk can be measured over time (incidence)

or at a given time (prevalence).

Adverse Event (AE)

Any untoward medical occurrence that may present during treatment with a pharmaceutical

product but which does not necessarily have a causal relationship with this treatment.

Adverse (Drug) Reaction (ADR)

A noxious and unintended response occurs at doses typically used in humans for the

prophylaxis, diagnosis, or therapy of disease or the modification of physiological function.

(WHO, 1972).

“A response to a medicinal product which is noxious and unintended.”

Allopathy

Non-traditional, western scientific therapy, usually uses synthesized ingredients but may also

contain a purified active ingredient extracted from a plant or other natural source, usually in

opposition to the disease.

Association

Events are associated with time but not necessarily linked to cause and effect.

Attributable risk

Difference between the risk in an exposed population (absolute risk) and the risk in an

unexposed population (reference risk). Attributable risk results from an absolute comparison

between outcome frequency measurements, such as incidence.

Biological products

Medical products prepared from biological material of human, animal or microbiologic

Causal relationship

A relationship between one phenomenon or event (A) and another (B) in which A precedes

and causes.

Causality assessment

1.The evaluation of the likelihood that a medicine was the causative agent of an

observed

2.adverse reaction. Causality assessment is usually made according to established

algorithms.

Caveat document

The formal advisory warning accompanying data release from the WHO Global ICSR

Database specifies the conditions and reservations applying to interpretations and use of the

data.

Cem-Flow

Software developed by UMC for collection and analysis of data in Cohort Event Monitoring.

Clinical trial

A systematic study on pharmaceutical products in human subjects (including patients and

other volunteers) to discover or verify the effects of and/or identify any adverse reaction to

investigational products and/or to study the absorption, distribution, metabolism, and

excretion (ADME) of the products to ascertain their efficacy and safety.

Cohort Event Monitoring

Cohort Event Monitoring (CEM) is a prospective, observational study of events that occur

during the use of medicines for intensified follow-up of selected medicinal products phase.

Patients are monitored from when they begin treatment and for a defined period.

Compliance

Faithful adherence by the patient to the prescriber’s instructions.

Control group

The comparison group in drug trials is not being given the studied drug.

Critical terms

Some of the terms in WHO-ART are marked as ‘Critical Terms’. These terms either refer to

or might indicate serious disease states and warrant special attention because of their possible

association with the risk of serious illness. This may lead to more decisive action than reports

on other terms.

Data mining

A general term for computerised extraction of potentially interesting patterns from large data

sets often based on statistical algorithms. A related term with essentially the same meaning is

‘pattern discovery’. The most familiar data mining application in pharmacovigilance is

disproportionality analysis, for example, using the Information component (IC).

De-challenge

The withdrawal of a drug from a patient; the point at which the continuity, reduction or

disappearance of adverse effects may be observed.

Disproportionality analysis

Screening of ICSR databases for reporting rates, which are higher than expected. For drug-

ADR pairs, common measures of disproportionality are the Proportional Reporting Ratio

(PRR), the Reporting Odds Ratio (ROR), The Information Component (IC), and the

Empirical Bayes Geometrical Mean (EBGM). There are also disproportionality measures for

drug-drug-ADR triplets, such as Omega (Ω).

Effectiveness/risk

The balance between the rates of effectiveness of a medicine versus the risk of harm is a

quantitative assessment of the merit of a medicine used in routine clinical practice.

Comparative information between therapies is most beneficial. This is more useful than the

efficacy and hazard predictions from pre-marketing information that is limited and based on

selected subjects.

Efficacy

The ability of a drug to produce the intended effect is determined by scientific methods, for

example, in pre-clinical research conditions (opposite of hazard).

Epidemiology

Science is concerned with studying the factors determining and influencing the frequency and

distribution of disease, injury and other health-related events and their causes in a defined

human population to establish programs to prevent and control their development and spread.

Essential medicines

Essential medicines are those that satisfy the priority healthcare needs of the population. They

are selected due to public health relevance, evidence on efficacy and safety, and comparative

cost-effectiveness.

Excipients

All materials included to make a pharmaceutical formulation (e.g. a tablet) except the active

drug substance(s).

Formulary

A listing of medicinal drugs with their uses, methods of administration, available doses,

dosage forms, side effects, etc, sometimes including their formulas and methods of

preparation.

Harm

The nature and extent of actual damage that a drug could cause. Not to be confused with risk.

Frequency of ADRs

In giving an estimate of the frequency of ADRs, the following standard categories are

recommended:

Very common* > 10%

Common (frequent) >1% and <10%

Uncommon (infrequent) >0.1% and < 1%

Rare >0.01% and <0.1%

Very rare* <0.01%

* Optional categories

Generic (multisource product)

The term ‘generic product’ has somewhat different meanings in different jurisdictions.

Generic products may be marketed either under the non-proprietary approved name or under

a new brand (proprietary) name. They are usually intended to be interchangeable with the

innovator product, which is usually manufactured without a license from the innovator

company and marketed after the expiry of patent or other exclusivity rights.

Herbal medicine

Includes herbs, herbal materials, herbal preparations and finished herbal products.

Homeopathy

Homeopathy is a therapeutic system which works on the principle that ‘like treats like’. An

illness is treated with a medicine which could produce similar symptoms in a healthy person.

The active ingredients are given in highly diluted form to avoid toxicity. Homeopathic

remedies are virtually 100% safe.

Information component (IC)

The Information component (IC) measures the disproportionality in the reporting of a drug-

ADR pair in an ICSR database relative to the reporting expected based on the overall

reporting of the drug and the ADR. Positive IC values indicate higher reporting than

expected. The IC has also been implemented on electronic health records to detect interesting

temporal relationships between drug prescriptions and medical events.

Incidence

Several new cases of an outcome develop over a defined period in a defined population at

risk.

Individual Case Safety Report (ICSR)

A report that contains ‘information describing a suspected adverse drug reaction related to the

administration of one or more medicinal products to an individual patient.’

MedDRA

MedDRA is the Medical Dictionary for Regulatory Activities. WHO-ART, the WHO

Adverse Reactions Terminology, is now mapped to MedDRA.

Medical error

“An unintended act (either of omission or commission) or one that does not achieve its

intended outcomes.”

Member countries

Countries which comply with the criteria for and have joined the WHO Programme for

International Drug Monitoring.

National Pharmacovigilance centres

Organisations recognised by governments to represent their country in the WHO Programme

(usually the drug regulatory agency). A single, governmentally recognized centre (or

integrated system) within a country with the clinical and scientific expertise to collect,

collate, analyse and give advice on all information related to drug safety.

Odds

The probability of an occurrence p is divided by the probability of its non-occurrence (1 - p).

Odds ratio

The Odds ratio in each population and the Odds in another population.

Omega (Ω)

A measure of disproportionate reporting for drug-drug-ADR triplets in ICSR databases,

designed to highlight potential signals of drug-drug interactions. Just like the more

established disproportionality measures for drug-ADR pairs, Ω is based on a contrast between

the observed and expected number of reports. A positive Ω indicates higher reporting than

expected.

OTC (Over the Counter) medicine

Medicinal products are available to the public without prescription.

Pani-Flow

Software developed by UMC for data collection and analysis in relation to vaccinations in a

pandemic situation.

Periodic Safety Update Report (PSUR)

A systematic review of the global safety data which became available to the manufacturer of

a marketed drug during a specific time period. Produced in an internationally agreed format.

Pharmacoepidemiology: Study of the use and effects of drugs in large populations.

Pharmacology: Study of the uses, effects, and modes of action of drugs.

Phocomelia

Characteristic deformity caused by exposure to thalidomide in the womb rarely occurs

spontaneously. Meaning: limbs like a seal.

Phytotherapy

Western-style scientific treatment using plant extracts or materials.

Placebo

An inactive substance (often called a sugar pill) is given to a group being studied to compare

results with the effects of the active drug.

Polypharmacy

The concomitant use of more than one drug, sometimes prescribed by different practitioners.

Post-marketing

The stage when a drug is generally available on the market.

Predisposing factors

Any aspect of the patient’s history (other than the drug) which might explain reported adverse

events (genetic factors, diet, alcohol consumption, disease history, polypharmacy or use of

herbal medicines, for example).

Prescription Event Monitoring (PEM)

The system was created to monitor adverse drug events in a population. Prescribers are

requested to report all events, regardless of whether they are suspected adverse events, for

identified patients receiving a specified drug. Also more accurately named Cohort Event

Monitoring.

Prescription Only Medicine (POM)

Medicinal products are available to the public only on prescription.

Prevalence

Number of existing cases of an outcome in a defined population at a given point in time.

Prophylaxis

Prevention or protection.

Rational drug use

An ideal of therapeutic practice in which drugs are prescribed and used according to the best

understanding of their appropriateness for the indication, the particular patient, and their

benefit, harm effectiveness and risk.

Pre-marketing

The stage before a drug is available for prescription or sale to the public.

Record linkage

Method of assembling information contained in two or more records, e.g. In different sets of

medical charts and vital records such as birth and death certificates. This makes it possible to

relate significant health events that are remote from one another in time and place.

Reference risk

Risk in a population of unexposed persons; also called baseline risk. Reference risk can be

measured over time (incidence) or at a given time (prevalence). The unexposed population

refers to a reference population, as closely comparable to the exposed population as possible,

apart from the exposure.

Regulatory authority

The legal authority in any country with the responsibility of regulating all matters relating to

drugs.

Relative risk

The risk ratio in an exposed population (absolute risk) and the risk in an unexposed

population (reference risk). Relative risk results from a relative comparison between outcome

frequency measurements, e.g. incidences.

Risk

The probability of harm being caused; the probability (chance, odds) of an occurrence.

Serious Adverse Event or Reaction

A serious adverse event or reaction is any untoward medical occurrence that at any dose:

results in death

requires inpatient hospitalization or prolongation of existing hospitalization

results in persistent or significant disability/incapacity is life-threatening.

Side effect

Any unintended effect of a pharmaceutical product occurring at normal dosage which is

related to the pharmacological properties of the drug.

Signal

Reported information on a possible causal relationship between an adverse event and a drug,

the relationship being unknown or incompletely documented previously. Usually, more than a

single report is required to generate a signal, depending upon the seriousness of the event and

the quality of the information. The publication of a signal usually implies the need for some

kind of review or action.

Summary of Product Characteristics (SPC)

A regulatory document attached to the marketing authorization which forms the basis of the

product information made available to prescribers and patients.

Spontaneous reporting

A system whereby case reports of adverse drug events are voluntarily submitted from health

professionals and pharmaceutical manufacturers to the national regulatory authority.

Thalidomide

Drugs prescribed in the 1950s as a mild sleeping pill and remedy for morning sickness for

pregnant women. This led to serious birth defects and the start of modern pharmacovigilance.

Returning to favour the treatment of serious diseases such as cancer and leprosy.

Traditional medicines

Traditional medicine is the sum total of the knowledge, skills, and practices based on the

theories, beliefs, and experiences indigenous to different cultures, whether explicable or not,

used in the maintenance of health as well as in the prevention, diagnosis, improvement or

treatment of physical and mental illness.

Unexpected adverse reaction

An adverse reaction, the nature or severity of which is not consistent with domestic

labelling or market authorization, or expected from characteristics of the drug.

Vigi-Base

The name of the WHO Global ICSR Database.

Vigi-Flow

Vigi-Flow is a complete ICSR management system created and maintained by the UMC. It is

web-based and built to adhere to the ICH-E2B standard. It can be used as the national

database for countries in the WHO Programme as it incorporates tools for report analysis and

facilitates sending reports to Vigi-Base.

Vigi-med

Share point-based conferencing facility, exclusive to member countries of the WHO

Programme for International Drug Monitoring for fast communication of topical

pharmacovigilance issues.

Vigi-Mine

A statistical tool within Vigi-Search with vast statistical material calculated for all Drug-

ADR pairs (combinations) available in Vigi-Base. The main features include the

disproportionality measure (IC value) stratified in different ways and valuable filter

capabilities.

Vigi-Search

A search service for accessing ICSRs stored in the Vigi-Base database offered by the UMC to

national pharmacovigilance centres and other third-party inquirers.

WHO-ART

Terminology for coding clinical information concerning drug therapy. UMC maintains WHO-

ART.

WHO Drug Dictionary (WHO DD)

The WHO Drug Dictionary is an international classification of drugs providing proprietary

and non-proprietary names of medicinal products used in different countries, together with all

active ingredients.

WHO-UMC Causality Assessment Scale

Causality term Assessment criteria*

Certain Events or laboratory test abnormalities, with plausible time relationship to drug

intake

It cannot be explained by disease or other drugs

Response to withdrawal plausible (pharmacologically, pathologically)

Event definitive pharmacologically or phenomenologically (i.e., an objective and specific

medical disorder or a recognized pharmacological phenomenon)

Rechallenge satisfactory, if necessary

Probable/ Likely

Event or laboratory test abnormality, with a reasonable time relationship to drug intake

Unlikely to be attributed to disease or other drugs

Response to withdrawal clinically reasonable

Rechallenge not required

Possible

Event or laboratory test abnormality, with reasonable time relationship to drug intake

It could also be explained by disease or other drugs

Information on drug withdrawal may be lacking or unclear

Unlikely

Event or laboratory test abnormality, with a time to drug intake that makes a relationship

improbable (but not impossible)

Disease or other drugs provide plausible explanations

Conditional/Unclassified

Event or laboratory test abnormality

More data for proper assessment is needed, or

Additional data under examination

Unassessable/ Unclassifiable

A report suggesting an adverse reaction

Cannot be judged because the information is insufficient or contradictory

Data cannot be supplemented or verified

SUSAR: An unexpected adverse reaction (UAR) is an adverse reaction that is not consistent

with the product information in the SPC.

A suspected unexpected serious adverse reaction (SUSAR) is any UAR that at any dose:

a. Results in death;

b. Is life threatening (i.e., the subject was at risk of death at the time of the event)

c. Refer to an event which hypothetically might have caused death if it were more severe

d. Requires hospitalization or prolongation of existing hospitalization;

e. Results in persistent or significant disability or incapacity;

f. Is a congenital anomaly or birth defect.

SUSAR is a serious adverse drug reaction (SAR) that is unexpected or for which the

development is uncommon (unexpected issue) observed during a clinical trial and for which

there is a relationship with the experimental drug, whatever the tested drug or its comparator.

Day zero remains as the day that the first information was received.

Day zero should be considered the day on which the minimum criteria for a reportable

adverse reaction report becomes available.

Medication errors occur during prescribing, transcribing, dispensing, administering,

adherence, or monitoring of a drug. Examples of medication errors include misreading or

miswriting a prescription. Medication errors that are stopped before harm can occur are

sometimes called “near misses” or “close calls” or, more formally, a potential adverse drug

event. Not all prescribing errors lead to adverse outcomes. Some do not cause harm, while

others are caught before harm can occur (“near-misses”).

Medication errors are more common than adverse drug events but result in harm less than

1% of the time. About 25% of adverse drug events are due to medication errors.

This refers to situations where the medicine is intentionally and inappropriately used not

under the authorized PI or the directions for use on the medicine label.

The adverse effect of a drug should not be considered without taking account of its beneficial

effects.

Collect and record of AEs / ADRs

Causality assessment and analysis of ADRs

Collate and code in the database

Compute risk-benefit and suggest regulatory action

Communicate for the safe use of drugs among stakeholders

Pristyn Research® & Pharmazone® Placement Records

Placement Success Stories, Alumni Career Outcomes & Industry Careers

Pristyn Research® and Pharmazone® are committed to helping students, fresh graduates and aspiring pharmaceutical professionals develop practical, industry-oriented skills for careers in Clinical Research, Pharmacovigilance, Clinical Data Management, Regulatory Affairs, Medical Writing, Medical Coding, Clinical Documentation, Pharmaceutical Research and related healthcare domains.

Our placement records showcase selected career outcomes of trainees who progressed into pharmaceutical, clinical research, healthcare, medical coding, clinical documentation and related professional roles after receiving training through Pristyn Research® and Pharmazone®.

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Our approach combines:

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The objective of our training is to help candidates understand industry concepts, develop practical knowledge, gain relevant exposure and become more confident when applying for professional opportunities.

Our Placement Records

The following are selected placement and career-success records represented in our official trainee placement creatives and records.

Clinical Research & Research-Related Careers

Fahad Hussain

Position: Research Coordinator
Location: GMC, Aurangabad

Akash Wadhe

Position: Clinical Research Coordinator (CRC)
Location: Nashik

Meenakshi Saindane

Position: Clinical Trial Assistant
Organization: Milagro Research
Location: Mumbai

Kavi Nivedita

Position: Clinical Research Coordinator
Organization: Research Allied Vision
Location: Nashik

Mohan Siraj

Position: Clinical Research Coordinator
Location: Aurangabad

Chandrakan Malhare

Position: Clinical Research Coordinator
Location: GMC, Aurangabad

Pooja Khillare

Position: Clinical Research Coordinator
Location: Aurangabad / GMC

Snehal Kanichke

Position: Clinical Data Summarizer
Location: Pune

Prasath Dhamale

Clinical Research-Related Career Outcome: Cognizant
Location: Pune

Tejashri Jadhav

Position: Clinical Trial Associate
Organization: Life Point Hospital
Location: Pune

Rahul Kakade

Position: Clinical Trial Associate
Organization: KlinEra Global
Location: Mumbai

Shantanu Joshi

Clinical Research-Related Career Outcome

Tanveer Shaikh

Organization: Milagro Research
Location: Mumbai

Pharmacovigilance, Safety & Pharmaceutical Careers

Pristyn Research® and Pharmazone® training also support career development in pharmaceutical safety, pharmacovigilance and related industry functions.

Harshada Khandagade

Position: Safety Data Analyst
Organization: Cognizant
Location: Pune
Package shown in placement record: ₹2.70 lakh per annum

The Safety Data Analyst outcome represents a career pathway associated with pharmaceutical safety and data-related functions.

Medical Coding & Healthcare Careers

Our placement records also include candidates who progressed into medical coding and healthcare information-management roles.

Prasad Mangdare

Position: Medical Coder
Organization: GEBBS Healthcare
Location: Aurangabad

Yogita Patil

Position: Medical Coder
Organization: GEBBS Healthcare
Location: Aurangabad

Kuldeep Ingle

Position: Medical Coder

Sapna Zini

Position: Medical Coder
Organization: Episource India Pvt. Ltd.
Location: Mumbai
Package shown in placement record: ₹2.1 lakh per annum

Clinical Data & Clinical Documentation Careers

The placement records demonstrate career outcomes extending into clinical data and clinical documentation functions.

Ankita Joshi

Position: Clinical Documentation Specialist
Organization: IKS Health
Location: Mumbai
Salary shown in placement record: ₹45,150 per month

Snehal Kanichke

Position: Clinical Data Summarizer
Location: Pune

These career outcomes demonstrate opportunities in clinical documentation, clinical data, healthcare documentation and related professional functions.

Selected Placement & Career Records

Akshay Sathe

Placement after Pristyn Research® training and placement program.

Pooja Salunkhe

Placement after Pristyn Research® training and placement program.
Organization: 3rd Gen
Location: Pune

Ganesh Dhake

Placement after Pristyn Research® training and placement program.
Organization: 3rd Gen

Ajit Tupte

Placement after Pristyn Research® training and placement program.
Organization: 3rd Gen
Location: Pune

Dinanath Warkad

Placement after Pristyn Research® training.
Organization: Cognizant

Pooja Narake

Placement after Pristyn Research® training.
Organization: Ascentrik Research
Package shown in placement record: ₹2,81,580 per annum

Ashwini Patil

Placement after Pristyn Research® training.
Organization: Ascentrik Research
Location: Pune
Salary shown in placement record: ₹23,500 per month

Shweta Jayaswal

Placement success record through Pristyn Research® training and placement program.

Shweta Diwate

Organization: Cognizant
Location: Pune

Kalyani K. Santosh

Organization: Covance India Pharmaceutical Pvt. Ltd.
Location: Mumbai
Position: Fresher
Salary shown in placement record: ₹29,602 per month

Supriya Chavan

Organization: Covance / Labcorp
Salary shown in placement record: ₹29,602 per month

Akshada Wale

Position: Associate
Organization: IKS Health Human Capital
Location: Mumbai
Freshers' salary shown in placement record: ₹17,000 per month

Candidate Placement Record – Accenture

Organization: Accenture
Location: Bengaluru
Position: BPO Associate
Salary shown in placement record: ₹28,323 per month

Shweta Diwate

Organization: Cognizant
Location: Pune

Prasad Mangdare

Position: Medical Coding Profile
Organization: GEBBS Healthcare
Location: Aurangabad

Shweta Jayaswal

Placement outcome: Placement through Pristyn Research® training and career support.

Sapna Zini

Position: Medical Coder
Organization: Episource India Pvt. Ltd.
Location: Mumbai
Freshers' package shown in placement record: ₹2.1 lakh per annum

Organizations Represented in Selected Placement Records

Selected trainee placement records supplied to Pristyn Research® and Pharmazone® include career outcomes associated with organizations such as:

Cognizant, IKS Health, Ascentrik Research, GEBBS Healthcare, Milagro Research, Research Allied Vision, Covance, Labcorp, Accenture, Life Point Hospital, KlinEra Global, Episource India Pvt. Ltd., 3rd Gen and other organizations represented in individual trainee records.

The organizations listed above are included because they appear in individual placement or career-success records.

Unless specifically stated, the appearance of an organization in a placement record does not imply a formal partnership, endorsement, recruitment agreement, sponsorship or institutional affiliation with Pristyn Research® or Pharmazone®.

Career Domains Represented in Our Placement Records

Our selected placement records demonstrate career outcomes across multiple pharmaceutical, healthcare and research-related domains, including:

Clinical Research

Clinical Research Coordinator
Clinical Trial Assistant
Clinical Trial Associate
Research Coordinator
Clinical Research Operations
Clinical Trial Support

Pharmacovigilance & Drug Safety

Safety Data Analyst
Pharmaceutical Safety
Drug Safety-related functions
Pharmacovigilance-related careers

Clinical Data Management

Clinical Data Summarizer
Clinical Data-related functions
Healthcare data-related roles

Medical Coding

Medical Coder
Medical Coding
Healthcare Information Management

Clinical Documentation

Clinical Documentation Specialist
Healthcare Documentation
Clinical Documentation-related functions

Pharmaceutical & Healthcare Careers

Pharmaceutical Research
Healthcare Research
Pharmaceutical Operations
Clinical Research Services
Life Sciences Careers

Selected Salary & Package Records

Some placement creatives include salary or package information reported at the time of the respective placement announcement.

Candidate	Organization	Salary / Package Shown
Harshada Khandagade	Cognizant	₹2.70 lakh/year
Supriya Chavan	Covance / Labcorp	₹29,602/month
Kalyani K. Santosh	Covance India Pharmaceutical Pvt. Ltd.	₹29,602/month
Accenture placement record	Accenture	₹28,323/month
Akshada Wale	IKS Health Human Capital	₹17,000/month
Ankita Joshi	IKS Health	₹45,150/month
Pooja Narake	Ascentrik Research	₹2,81,580/year
Ashwini Patil	Ascentrik Research	₹23,500/month
Sapna Zini	Episource India Pvt. Ltd.	₹2.1 lakh/year

Salary and package figures shown above are historical figures appearing in the respective placement creatives. They are not guaranteed current salaries, future salary expectations or employment guarantees.

From Academic Knowledge to Industry-Ready Skills

A pharmacy or life-science degree provides an important academic foundation.

Professional success also requires the ability to understand and apply industry concepts.

At Pristyn Research® and Pharmazone®, our career-oriented training approach focuses on:

Learn

Understand pharmaceutical, clinical research and healthcare industry concepts.

Practise

Work on practical assignments and industry-oriented activities.

Build Your Profile

Develop professional CVs, resumes, LinkedIn profiles and career documentation.

Prepare

Develop confidence for technical interviews, HR interviews and practical interview questions.

Pursue Opportunities

Use acquired knowledge and skills to independently apply for suitable employment opportunities.

Our Training & Career Development Areas

Pristyn Research® and Pharmazone® provide training and career-development opportunities in areas including:

Pharmacovigilance Training

Clinical Research Training

Clinical Data Management Training

Regulatory Affairs Training

Scientific & Medical Writing Training

Medical Writing Training

Pharmaceutical Research Training

Healthcare Research Training

Clinical Research Internship

Pharmacovigilance Internship

Clinical Data Management Internship

Regulatory Affairs Internship

Scientific Research Internship

Career Development for Pharmacy Graduates

Industry-Oriented Training for Pharmacy Students

Practical Training for Life Science Graduates

Interview Preparation for Pharmaceutical Jobs

Pharmaceutical Career Guidance

Clinical Research Career Preparation

Pharmacovigilance Career Preparation

Why We Publish Placement Records

Students choosing a professional training program deserve access to real examples of career outcomes.

Our placement records are published to provide prospective candidates with a transparent view of selected trainee career journeys and employment outcomes associated with our training and career-development ecosystem.

These records may include:

Candidate names
Candidate photographs
Educational background
Training program
Job designation
Organization
Location
Salary/package information
Candidate testimonials
Placement announcements
Career-success photographs
Other supporting placement information

Candidate information should be published with appropriate consent and permission.

Placement Success Stories

Explore selected placement announcements and trainee career-success stories through our official social-media records.

Official Placement Highlights:
https://www.instagram.com/stories/highlights/17995610504093000/

Additional Placement Success Record:
https://www.instagram.com/p/CYtEOUuoxOJ/

Our social-media placement records complement the placement information presented on this webpage.

Is Pharmazone® a Placement Agency?

No.

Pharmazone® is primarily a training and career-development platform associated with Pristyn Research®.

Our focus is on:

Practical Training + Industry Knowledge + Internship/Practical Exposure + Career Guidance + Interview Preparation + Placement Assistance

Placement assistance is intended to help candidates identify, prepare for and pursue suitable employment opportunities.

Employment is not guaranteed.

Individual career outcomes depend on a candidate's educational qualification, skills, practical knowledge, experience, interview performance, communication abilities, employer requirements, location, job market conditions and other individual factors.

Does Pharmazone® Provide Placement Assistance?

Yes. Career and placement assistance forms part of the broader career-development approach associated with Pharmazone®.

Candidates may receive support related to:

Career guidance
Resume/CV development
LinkedIn profile development
Interview preparation
Technical interview preparation
HR interview preparation
Mock interviews
Job opportunity information
Industry knowledge
Practical assignments
Internship/practical exposure
Professional communication
Career planning

The objective is to help candidates become better prepared to independently pursue suitable career opportunities.

What Careers Can Pharmacy Graduates Pursue After Industry-Oriented Training?

Pharmacy graduates and life-science professionals may explore career opportunities across areas such as:

Clinical Research, Pharmacovigilance, Drug Safety, Clinical Data Management, Regulatory Affairs, Medical Writing, Scientific Research, Clinical Documentation, Medical Coding, Healthcare Research, Pharmaceutical Operations and related life-science functions.

Career opportunities depend on the candidate's qualification, skills, experience and employer requirements.

What Is the Difference Between Training and Placement?

Training develops knowledge and practical skills.

Internship provides practical exposure where applicable.

Career preparation helps candidates develop professional profiles and interview readiness.

Placement assistance helps candidates identify and pursue suitable employment opportunities.

Employment is ultimately determined by the employer and the candidate's individual performance and suitability.

Pristyn Research® & Pharmazone® Career Philosophy

Don't Just Add Another Certificate to Your CV.

A certificate can demonstrate that a candidate completed a training program.

During an interview, however, candidates need to demonstrate what they actually know and can do.

We therefore encourage candidates to develop the ability to explain:

Pharmaceutical industry terminology
Clinical research processes
Clinical trial documentation
Pharmacovigilance concepts
Drug safety processes
Clinical data concepts
Regulatory requirements
Scientific and medical writing principles
Research methodology
Industry documentation
Practical assignments
Interview scenarios

Our philosophy:

Learn → Practise → Build Your Profile → Prepare → Pursue Opportunities

About Pristyn Research®

Pristyn Research® is a research and scientific services organization associated with pharmaceutical, healthcare and clinical research activities.

The organization works across areas including:

Clinical Research
Scientific Research
Research Writing
Medical Writing
Regulatory Affairs
Clinical Trial Operations
Pharmacovigilance
Clinical Data Management
Pharmaceutical Research
Healthcare Research
Research and career-oriented education

Pristyn Research®
Advancing Research. Empowering Innovation.

Official Website:
https://www.pristynresearch.com/

About Pharmazone®

Pharmazone® is the training and career-development platform associated with Pristyn Research®.

Pharmazone® focuses on practical and industry-oriented training for students, fresh graduates and professionals seeking career opportunities in pharmaceutical and healthcare research.

Key training areas include:

Pharmacovigilance
Clinical Research
Clinical Data Management
Regulatory Affairs
Scientific & Medical Writing
Pharmaceutical Research
Healthcare Research
Internship and practical exposure
Career development
Interview preparation

Pharmazone® — Transforming Knowledge into Careers

Official Website:
https://pharmazone.co.in/

Frequently Asked Questions

What are the placement records of Pharmazone®?

Pharmazone® maintains selected trainee placement and career-success records covering Clinical Research, Pharmacovigilance, Clinical Data Management, Medical Coding, Clinical Documentation and other pharmaceutical and healthcare-related career areas.

What are the placement records of Pristyn Research®?

Pristyn Research® and its associated training platform Pharmazone® have documented selected trainee career outcomes through placement announcements, candidate success stories and related records.

Which companies appear in Pharmazone® placement records?

Selected records supplied for this placement page include organizations such as Cognizant, IKS Health, Ascentrik Research, GEBBS Healthcare, Milagro Research, Research Allied Vision, Covance/Labcorp, Accenture, Life Point Hospital, KlinEra Global, Episource India Pvt. Ltd. and 3rd Gen.

Which jobs have Pharmazone® trainees obtained?

Selected records include Clinical Research Coordinator, Clinical Trial Assistant, Clinical Trial Associate, Research Coordinator, Safety Data Analyst, Clinical Data Summarizer, Medical Coder, Clinical Documentation Specialist, Associate, BPO Associate and other pharmaceutical and healthcare-related roles.

Does Pharmazone® guarantee placement?

No. Pharmazone® provides training, career guidance and placement assistance, but employment is not guaranteed.

Does Pristyn Research® provide internships?

Pristyn Research® and Pharmazone® provide internship and practical-exposure opportunities in selected pharmaceutical, clinical research, pharmacovigilance, clinical data, regulatory and scientific research areas, depending on the relevant program and eligibility.

Is Pharmazone® suitable for pharmacy students?

Pharmazone® provides industry-oriented training designed for students and graduates from pharmacy, life sciences and related healthcare backgrounds, subject to individual program eligibility.

Is Pharmazone® suitable for freshers?

Yes. Selected training programs are designed to help fresh graduates understand industry concepts, develop practical knowledge, prepare professional profiles and become better prepared for entry-level pharmaceutical and healthcare career opportunities.

Which course is useful for a Pharmacovigilance career?

Pharmacovigilance training can help candidates understand drug safety, adverse event concepts, safety data, case-processing principles and related pharmaceutical safety functions. Individual employment outcomes depend on candidate qualifications, skills and employer requirements.

Which course is useful for a Clinical Research career?

Clinical Research training can help candidates understand clinical trials, clinical research processes, study documentation, clinical trial terminology and related industry functions.

Which course is useful for Clinical Data Management careers?

Clinical Data Management training focuses on concepts and practical knowledge associated with clinical data, data management processes, clinical databases and related clinical research functions.

Which course is useful for Regulatory Affairs careers?

Regulatory Affairs training introduces candidates to pharmaceutical regulatory concepts, regulatory documentation, regulatory processes and related industry functions.

Which course is useful for Medical Writing careers?

Scientific and Medical Writing training helps candidates understand scientific communication, research writing, medical writing principles, literature-based writing and professional documentation.

Our Placement & Career Commitment

We believe that meaningful career preparation goes beyond classroom theory.

Our objective is to help candidates develop:

Knowledge

Practical Skills

Industry Understanding

Professional Confidence

Interview Readiness

Career Awareness

Practical Exposure

Professional Communication

Job-Application Readiness

Ultimately, every candidate must use these skills, qualifications and opportunities to build their own career.

Important Placement Disclaimer

Placement and career outcomes published on this page represent selected records maintained and/or shared by Pristyn Research® and Pharmazone®.

Past placement outcomes do not guarantee future employment, salary, designation, employer or career progression.

Salary and package figures represent information displayed in the respective placement creatives at the time of publication and should not be considered current or guaranteed compensation.

Pristyn Research® and Pharmazone® are primarily training and career-development organizations and are not placement agencies.

Placement assistance and career guidance do not constitute a guarantee of employment.

Individual career outcomes vary according to educational qualification, skills, practical knowledge, experience, interview performance, communication abilities, employer requirements, location, market conditions and other factors.

Organization names appearing in individual placement records are presented in connection with the respective candidate records. Unless specifically stated, their inclusion does not imply endorsement, partnership, sponsorship, recruitment authorization or formal affiliation with Pristyn Research® or Pharmazone®.

Candidate photographs, names, testimonials and other personal information should be published with appropriate consent and permission.

Pristyn Research® & Pharmazone®

Learn. Practise. Prepare. Build Your Career.

Pristyn Research®
Advancing Research. Empowering Innovation.

Pharmazone®
Transforming Knowledge into Careers

Training • Internship • Practical Skills • Career Development • Interview Preparation • Placement Assistance

Official Websites

Pristyn Research®: https://www.pristynresearch.com/

Pharmazone®: https://pharmazone.co.in/

FREQUENTLY ASKED PHARMACOVIGILANCE INTERVIEW QUESTIONS WITH ANSWERS

1.What is Pharmacovigilance?

2.According to WHO, what minimum criterion is required for a valid case?

3.What is an Adverse Drug Event (ADE)?

4.When do you consider an event to be serious?

5.Name the regulatory bodies in the USA, UK, Japan, and India.

7.When do you consider a case to be medically confirmed?

8.What do you mean by causality?

9.Name some data elements in ICSR.

10.What should a narrative consist of?

11.Explain the hierarchy in MedDRA.

12.What do you know about E2a, E2b and E2c guidelines?

13.State the benefits of the Pharmacovigilance program.

14.Role of Drug Safety Associate.

15.What are the objectives in Pharmacovigilance?

16.What are the types of Pharmacovigilance (PV)?

17.What are the due dates for safety reporting?

18.What are Data assessments in Pharmacovigilance?

19.Aim of pharmacovigilance.

20.What is Pharmacovigilance centre (PvC)?

21.What is Spontaneous reporting?

22.Suitable methods of reporting:

23.What is WHO ART, WHO DD and MedDRA and the difference between them?

24.What is Cemflow?

25.What to report in PV?

26.Seriousness criteria based on intensity?

27.Synonyms for relatedness (causality-related)?

28.Synonyms for relatedness (causality- unrelated)?

29.Odd scenarios in PV?

30.What are Co-morbid conditions?

31.What is a signal?

32.Methods of signal detection?

33.Full form of PV terms?

34.Outcome of the event

35.Re-challenge

36.De-challenge

37.International Society of Pharmacovigilance (ISOP)

38.Definitions you should know before applying for PV?

39.In pharmacovigilance, a medicine causing an adverse reaction.

40.What is SUSAR:

41.What is Day zero?

42.Medication Errors

43.Misuse

44.Beneficial effects

45.Process in Pharmacovigilance

Placement records

Pristyn Research® & Pharmazone® Placement Records

Placement Success Stories, Alumni Career Outcomes & Industry Careers

Don't Just Earn a Certificate. Build Skills You Can Demonstrate in an Interview.

Our Placement Records

Clinical Research & Research-Related Careers

Fahad Hussain

Akash Wadhe

Meenakshi Saindane

Kavi Nivedita

Mohan Siraj

Chandrakan Malhare

Pooja Khillare

Snehal Kanichke

Prasath Dhamale

Tejashri Jadhav

Rahul Kakade

Shantanu Joshi

Tanveer Shaikh

Pharmacovigilance, Safety & Pharmaceutical Careers

Harshada Khandagade

Medical Coding & Healthcare Careers

Prasad Mangdare

Yogita Patil

Kuldeep Ingle

Sapna Zini

Clinical Data & Clinical Documentation Careers

Ankita Joshi

Snehal Kanichke

Selected Placement & Career Records

Akshay Sathe

Pooja Salunkhe

Ganesh Dhake

Ajit Tupte

Dinanath Warkad