Top 30 Pharmacovigilance Interview Questions for Freshers in India (2025)

Pharmacovigilance (PV) interviews in India follow a surprisingly predictable pattern. Whether you're interviewing at IQVIA, Parexel, Accenture Syntel, or a mid-size CRO, the questions fall into three buckets:

1. Core PV definitions and processes
2. Case processing and ICSR knowledge
3. Regulations and guidelines

This guide covers the 30 most commonly asked questions, with model answers and what the interviewer is actually testing.

Section 1: Core PV Definitions

1. What is Pharmacovigilance?

Model answer: Pharmacovigilance is the science and activity related to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problems.

What the interviewer is testing: Whether you know the WHO/ICH definition. Always say "detection, assessment, understanding, and prevention" — in that exact order.

2. What is an Adverse Drug Reaction (ADR)?

Model answer: An ADR is a response to a medicinal product which is noxious and unintended, occurring at normal doses used in humans. The key word is "unintended" — it excludes intentional overdose.

Don't confuse with Adverse Event (AE): An AE is any undesirable experience in a patient taking a medicinal product, regardless of whether it's causally related to the drug.

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

| Term | Causality to drug | Usage context | |---|---|---| | Adverse Event (AE) | Not established | Clinical trials | | Adverse Drug Reaction (ADR) | Established | Post-marketing surveillance |

An AE becomes an ADR when causality is at least "possible."

4. What is a Serious Adverse Event (SAE)?

Model answer: An SAE is any adverse event that results in:

• Death
• Life-threatening condition
• Hospitalisation or prolonged hospitalisation
• Persistent or significant disability/incapacity
• Congenital anomaly or birth defect
• Important medical event (judged by the investigator)

5. What is an Unexpected Adverse Drug Reaction?

An unexpected ADR is one whose nature, severity, specificity, or outcome is not consistent with the Reference Safety Information (RSI) — typically the Investigator's Brochure (IB) for clinical trials or the Summary of Product Characteristics (SmPC) for approved drugs.

6. What is a SUSAR?

A SUSAR (Suspected Unexpected Serious Adverse Reaction) is a serious adverse reaction that is:

• Suspected to be related to the investigational product
• Unexpected (not in the RSI)
• Serious

SUSARs must be expeditiously reported to regulatory authorities — 7 days for fatal/life-threatening, 15 days for all others.

Section 2: ICSR (Case Processing)

7. What is an ICSR?

An Individual Case Safety Report (ICSR) is a report of one or more adverse events in a single patient on a specific medicinal product. It's the basic unit of pharmacovigilance.

Every ICSR must have 4 minimum criteria (the "valid case" criteria):

1. An identifiable patient
2. An identifiable reporter
3. A suspect drug
4. An adverse event

8. What is the ICSR reporting timeline?

| Case Type | Reporting Deadline | |---|---| | Fatal/Life-threatening SUSAR | 7 calendar days | | All other SUSARs | 15 calendar days | | Non-serious | 30 calendar days |

9. What are the sources of ICSRs?

• Spontaneous reports: Healthcare professionals, patients, consumers
• Clinical trials: SAE reports from investigators
• Literature: Published case reports (you must screen for valid ICSRs)
• Digital/Social media: Increasing source in modern PV
• Health authority: ICSRs received from regulatory agencies

10. What is case narrative?

A case narrative is a chronological, factual, and concise written summary of the adverse event(s) in an ICSR. It should answer: Who, What, When, Why, and What happened.

A good narrative includes: patient demographics, medical history, suspect drug and dosage, timeline of events, treatment of the AE, and outcome.

11. What is medical coding in PV?

Medical coding converts verbatim (free-text) terms used by reporters into standardised dictionary terms.

• Adverse events → coded to MedDRA (Medical Dictionary for Regulatory Activities)
• Medications → coded to WHO-DD (WHO Drug Dictionary)

MedDRA has 5 levels: SOC → HLGT → HLT → PT → LLT

12. What is the MedDRA hierarchy?

SOC    → System Organ Class (e.g., "Cardiac disorders")
HLGT   → High Level Group Term
HLT    → High Level Term
PT     → Preferred Term (the primary coding level)
LLT    → Lowest Level Term (verbatim maps here)

The Preferred Term (PT) is the most important level — it's what regulators analyse.

Section 3: Regulations and Guidelines

13. What is ICH E2A?

ICH E2A defines clinical safety data management standards — specifically the definitions and terminology for expedited reporting of ICSRs during clinical trials. It introduced the SAE/SUSAR framework.

14. What is ICH E2B?

ICH E2B specifies the electronic transmission format for ICSRs — currently E2B(R3). All regulatory submissions use this XML-based format.

15. What is the EU Pharmacovigilance legislation?

The EU PV legislation is Directive 2010/84/EU and Regulation 1235/2010, strengthened by EMA's Good Pharmacovigilance Practices (GVP) guidelines.

Key features:

• Made MAH (Marketing Authorisation Holder) directly responsible for PV
• Mandatory pharmacovigilance system
• PSMF (Pharmacovigilance System Master File)
• PSUR (Periodic Safety Update Reports)

16. What is a PSUR?

A Periodic Safety Update Report (PSUR) is a periodic comprehensive safety update submitted by the MAH to regulators. It reviews all safety data collected over a defined period to assess whether the benefit-risk profile of the drug remains favourable.

In the EU it's called PBRER (Periodic Benefit-Risk Evaluation Report) under ICH E2C(R2).

17. What is the role of WHO-UMC in PV?

The WHO Uppsala Monitoring Centre (UMC) is the WHO collaborating centre for international drug monitoring. It maintains VigiBase, the world's largest database of individual case safety reports with over 30 million entries.

18. What is causality assessment?

Causality assessment evaluates the likelihood that a drug caused the adverse event.

WHO-UMC Causality Categories:

| Category | Meaning | |---|---| | Certain | Plausible time relationship, confirmed on rechallenge | | Probable/Likely | Plausible, no other explanation, dechallenge positive | | Possible | Plausible, but other drugs or diseases could explain | | Unlikely | Temporal relationship improbable | | Conditional/Unclassified | More data needed | | Unassessable | Insufficient information |

Section 4: Process and Operations

19. What is the lifecycle of an ICSR?

Case Receipt → Triage (valid/invalid) → Data Entry → Medical Coding → 
Medical Review → Quality Check → Submission to Regulatory Authority → 
Follow-up (if needed) → Case Closure

20. What is a follow-up report?

A follow-up is an update to a previously submitted ICSR with new or corrected information. Common triggers: outcome update, additional medical history, lab values.

21. What is a literature review in PV?

Systematic searching of scientific literature (PubMed, Embase, etc.) to identify new safety signals or case reports that should be captured as ICSRs. MAHs are legally required to conduct regular literature reviews.

22. What is a signal in PV?

A signal is information arising from one or more sources suggesting a new potentially causal association between a drug and an adverse event that is unknown or incompletely documented.

Signal detection methods include:

• Disproportionality analysis (PRR, ROR)
• Bayesian methods (BCPNN used by WHO-UMC)
• Clinical review

Section 5: Tools and Systems

23. What is Argus Safety?

Oracle Argus Safety is the most widely used PV case processing system globally. It's a web-based platform for receiving, processing, and submitting ICSRs. Most large CROs (IQVIA, Parexel, ICON) use Argus.

24. What is Veeva Vault Safety?

Veeva Vault Safety is a cloud-based PV system increasingly adopted as an alternative to Argus, particularly by mid-size pharma companies and CROs.

25. What is EudraVigilance?

EudraVigilance is the European database for reporting and evaluating suspected adverse drug reactions. All marketing authorisation holders in the EU are required to submit ICSRs to EudraVigilance.

Section 6: Scenario-Based Questions

26. A patient calls to report that she felt dizzy after taking a medication. Is this a valid ICSR?

Yes, if:

• The caller is the patient herself (identifiable patient + identifiable reporter)
• She names the medication (suspect drug)
• Dizziness is the adverse event

All 4 minimum criteria are met. This is a valid spontaneous ICSR.

27. You receive a case with a fatal outcome but no causality. What do you do?

You must still report it. Causality is not a criterion for reporting SAEs. A fatal outcome makes it a serious case requiring 7-day expedited reporting as a potential SUSAR. You investigate causality afterwards.

28. You see a social media post mentioning side effects of a drug. What's your responsibility?

Social media monitoring is now part of modern PV. If you identify a post that meets the 4 minimum criteria for a valid ICSR, it must be processed as a case. The identifiable patient and reporter can be the same person. Screen, document, and process accordingly.

29. What is the difference between spontaneous reporting and clinical trial reporting?

| Feature | Spontaneous | Clinical Trial | |---|---|---| | Source | Voluntary HCP/patient reports | Mandatory investigator reports | | Causality | Assumed | Assessed by investigator | | Timeframe | Post-marketing | During study conduct | | Requirement | Not mandatory | Mandatory per protocol |

30. How do you handle a duplicate case?

First, check if the case matches any previously received reports (same patient, reporter, event, date). If confirmed duplicate, maintain the original case and mark the new one as duplicate. Document your reasoning in the audit trail.

Final Prep Tips

• Don't memorise — understand. Interviewers can tell immediately when you're reciting vs. reasoning.
• Know MedDRA and ICH E2A cold. These come up in every PV interview.
• Be ready for scenario questions. The examples above are real scenarios that IQVIA and Parexel interviewers use.
• Know at least one PV system — Argus is most common; even just knowing the workflow gives you a massive edge.

Use ClinPath's Virtual Interview Prep to practice these questions with AI scoring. Select Pharmacovigilance as your domain and Fresher as your level.

Good luck — you've already done the hardest part by preparing seriously.