Top 21 Pharmacovigilance Interview Questions

Basic pharmacovigilance interview questions for freshers

Most pharmacovigilance interview questions start here. These answers show you know what drug safety is. They also show where it fits in a medicine’s life.

1. 1What is pharmacovigilance?

   The World Health Organization defines pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.” In simple terms, it is the work of keeping patients safe from the harmful effects of medicines.

2. 2What are the types of pharmacovigilance?

   There are two broad types:

   • Passive pharmacovigilance relies on spontaneous reports. Doctors, pharmacists, patients and companies report suspected reactions voluntarily.
   • Active pharmacovigilance looks for adverse events on purpose — for example through registries, cohort event monitoring or sentinel sites.

3. 3Is pharmacovigilance only about drugs?

   No. The same principles apply to vaccines, biologicals, blood products and herbal or traditional medicines. Related fields cover medical devices (materiovigilance) and cosmetics (cosmetovigilance).

4. 4What are the phases of clinical trials?

   Before a medicine is approved it passes through phased studies:

   • Phase I: a small group, often healthy volunteers, to study safety, dose and how the body handles the drug.
   • Phase II: patients with the condition, to study efficacy and side effects.
   • Phase III: hundreds to thousands of patients, usually randomised and blinded, to confirm benefit and monitor adverse reactions.
   • Phase IV: after approval, to monitor long-term safety in the wider population (post-marketing surveillance).

5. 5Name the drug regulators in the USA, UK, EU, Japan and India.

   Each region has its own regulator:

   • USA: Food and Drug Administration (FDA)
   • UK: Medicines and Healthcare products Regulatory Agency (MHRA)
   • European Union: European Medicines Agency (EMA)
   • Japan: Ministry of Health, Labour and Welfare (MHLW), with the PMDA
   • India: Central Drugs Standard Control Organisation (CDSCO). The Pharmacovigilance Programme of India (PvPI) collects adverse reaction reports.

Adverse events, reactions and case questions

This is the heart of case processing, and the source of most technical pharmacovigilance interview questions. Expect follow-ups and short scenarios.

1. 6What is an adverse event (AE)?

   ICH E2A defines an adverse event as “any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.” The key point: an AE does not need to be caused by the drug.

2. 7What is an adverse drug reaction (ADR)?

   An ADR is a harmful and unintended response to a medicine. There must be at least a reasonable possibility that the medicine caused it. Before approval, ICH E2A covers responses at any dose. After approval, the WHO definition covers doses normally used to prevent, diagnose or treat disease.

3. 8What is the difference between an AE and an ADR?

   An adverse event is any unwanted medical occurrence while taking a medicine, whether or not the medicine caused it. It becomes an adverse drug reaction when there is a reasonable possibility that the medicine caused it. So every ADR is an AE, but not every AE is an ADR.

4. 9What are the minimum criteria for a valid case?

   A case is valid for reporting when it has all four:

   1. An identifiable reporter
   2. An identifiable patient
   3. At least one suspect product
   4. At least one adverse event or reaction

5. 10When is an adverse event serious?

   Under ICH E2A, an event is serious if it:

   • Results in death
   • Is life-threatening
   • Requires hospitalisation or prolongs an existing hospital stay
   • Results in persistent or significant disability or incapacity
   • Is a congenital anomaly or birth defect
   • Is otherwise medically important, based on medical judgement

   For medical devices, the US FDA also counts an event that needed intervention to prevent permanent impairment or damage.

6. 11What is expectedness?

   An event is expected if its nature and severity match the reference safety information — the Investigator’s Brochure during a trial, or the approved product label (such as the USPI or SmPC) after approval. If it does not match, it is unexpected. You may also hear “listed” (in the company core safety information) and “labelled” (in the local label).

7. 12What do you mean by causality?

   Causality is the link between the suspect product and the adverse event. Assessors use methods such as the WHO-UMC system or the Naranjo scale. WHO-UMC uses categories like certain, probable, possible and unlikely. Assessors look at timing, dechallenge (does it improve when the drug stops?), rechallenge and other possible causes.

8. 13What is the difference between concomitant medications and past drugs?

   Concomitant medications are taken at the same time as the suspect drug, even if they were started earlier. Past drugs were stopped before the suspect drug was started. Both matter when you assess other possible causes of an event.

Pharmacovigilance interview questions on reporting and signals

1. 14What would you do if you had an adverse effect from a medicine?

   Contact my doctor and get medical help. I would not stop a prescribed medicine without advice. Then I would report it, either to the manufacturer or to the national reporting system — for example PvPI in India.

2. 15As a healthcare professional, how would you report an adverse drug reaction?

   It depends on the country, because each has its own system. First I would collect full case details: patient, suspect drug, event, dates and outcome. Then I would report to the national system or to the company that holds the licence. Examples are PvPI in India, MedWatch in the USA and the Yellow Card scheme in the UK.

3. 16What is a SUSAR?

   SUSAR stands for Suspected Unexpected Serious Adverse Reaction. It is a reaction in a clinical trial that meets three tests. It is serious. It is unexpected, based on the reference safety information. And it is suspected to be caused by the trial drug. Under ICH E2A, fatal or life-threatening SUSARs are reported within 7 days, and others within 15 days.

4. 17Which FDA form is used for mandatory reporting?

   MedWatch Form 3500A is used for mandatory reporting by manufacturers, importers and user facilities. Healthcare professionals use Form 3500 for voluntary reports, and consumers use Form 3500B.

5. 18What is a signal?

   A signal is reported information on a possible causal link between an adverse event and a medicine. The link was unknown, or not fully documented, before. Usually more than one report is needed. How many depends on how serious the event is and how good the information is.

MedDRA, ICH guideline and abbreviation questions

1. 19What is MedDRA, and what is its hierarchy?

   MedDRA is the Medical Dictionary for Regulatory Activities, a standard medical terminology developed under ICH and used to code adverse events, medical history and indications. It has five levels, from broadest to most specific:

   • System Organ Class (SOC)
   • High Level Group Term (HLGT)
   • High Level Term (HLT)
   • Preferred Term (PT)
   • Lowest Level Term (LLT)

   Coders choose the Lowest Level Term that best matches the reporter’s words. Each LLT links to one Preferred Term, which is used for analysis.

2. 20What do the ICH E2A, E2B and E2C guidelines cover?

   They are the core ICH safety guidelines:

   • E2A: clinical safety data management — definitions and standards for expedited reporting
   • E2B(R3): data elements for electronic transmission of individual case safety reports (ICSRs)
   • E2C(R2): the Periodic Benefit-Risk Evaluation Report (PBRER), which replaced the older PSUR format

   Related guidelines include E2D (post-approval safety data), E2E (pharmacovigilance planning) and E2F (the Development Safety Update Report).

3. 21Expand these common pharmacovigilance abbreviations.

   Interviewers often ask you to expand a few of these:

   • AE / ADE: Adverse Event / Adverse Drug Event
   • ADR: Adverse Drug Reaction
   • SAE: Serious Adverse Event
   • SUSAR: Suspected Unexpected Serious Adverse Reaction
   • ICSR: Individual Case Safety Report
   • PSUR / PBRER: Periodic Safety Update Report / Periodic Benefit-Risk Evaluation Report
   • DSUR: Development Safety Update Report
   • CIOMS: Council for International Organizations of Medical Sciences
   • ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
   • IBD: International Birth Date

How to prepare for a pharmacovigilance interview

Knowing the answers is only half the job. Here is how to turn them into a confident interview.

1. 1

   Learn the definitions exactly

   Read ICH E2A once, slowly. Interviewers notice when you use the official wording for AE, ADR and seriousness.

2. 2

   Explain with an example

   For each answer, add one line from real life — for example, a rash after an antibiotic as an AE that may be an ADR.

3. 3

   Practise the practical round

   Many drug safety employers test case triage, MedDRA coding or a short narrative. Practise on sample cases before the day.

4. 4

   Know your safety database

   If you have used a safety database in training, be ready to describe the case workflow you followed in it.

5. 5

   Prepare your own story

   Have a two-minute answer ready for “Why pharmacovigilance?” that links your degree to patient safety.

What experienced candidates are asked

Pharmacovigilance interview questions for experienced candidates go deeper into your own work. Prepare real examples for these topics:

• Aggregate reports — what goes into a PBRER or DSUR, and your role in one
• Signal detection and management — from data review to validation
• E2B(R3) submissions and regulatory timelines for expedited reports
• Quality checks, audits, inspections and corrective and preventive actions (CAPA)
• Literature screening and how you decide whether an article contains a valid case
• Your safety database experience and how you handle duplicate or follow-up cases

Freshers moving into drug safety may also like our guide to the pharmacovigilance internship program.

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