Pharmacovigilance plays a critical role in ensuring the safety of medicines, making it a dynamic and highly regulated field. Whether you’re a fresh graduate or an experienced professional transitioning into drug safety, preparing for interviews can be daunting. This article explores the most commonly asked pharmacovigilance interview questions — from case processing and regulatory frameworks to signal detection and safety databases — helping you walk in with confidence and clarity. Here are few Pharmacovigilance Interview Questions that will make you prepared before your interview.
Fundamentals of Pharmacovigilance
1. What is pharmacovigilance and why is it important?
Answer:
Pharmacovigilance (PV) is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
It is important because it ensures patient safety, improves the safe use of medicines, and supports regulatory decisions such as updating product labels or restricting drug use if risks outweigh benefits.
2. Define an Adverse Drug Reaction (ADR) and an Adverse Event (AE). How do they differ?
Answer:
- Adverse Event (AE): Any untoward medical occurrence after using a medicinal product, regardless of whether there is a causal relationship.
- Adverse Drug Reaction (ADR): A noxious and unintended response to a drug where a causal relationship between the drug and the event is suspected.
Difference: ADR implies causality; AE does not.
3. What is the role of the WHO in pharmacovigilance?
Answer:
The World Health Organization (WHO) coordinates the global PV program through the Uppsala Monitoring Centre (UMC) in Sweden. It collects and analyzes reports from member countries in VigiBase, provides tools like VigiLyze, and issues guidance to strengthen global drug safety systems.
4. What are the main objectives of pharmacovigilance?
Answer:
- Detect unknown or rare adverse reactions.
- Assess and manage risks related to drug use.
- Improve patient care and safety.
- Communicate findings to healthcare professionals and the public.
- Support regulatory decision-making and product labeling.
📋 Case Processing & ICSR
5. What are the key components of an Individual Case Safety Report (ICSR)?
Answer:
The four essential elements of a valid ICSR are:
- Identifiable patient
- Identifiable reporter
- Suspect drug(s)
- Adverse event(s)
Other key details include medical history, dosage, route, treatment dates, outcomes, and company or literature references.
6. How do you determine the seriousness of an adverse event?
Answer:
An event is serious if it results in:
- Death
- Life-threatening situation
- Hospitalization (initial or prolonged)
- Disability or permanent damage
- Congenital anomaly/birth defect
- Other medically significant conditions (requiring intervention to prevent the above).
7. What is MedDRA and how is it used in pharmacovigilance?
Answer:
MedDRA (Medical Dictionary for Regulatory Activities) is a standardized medical terminology used to code adverse events, indications, and medical history consistently in safety databases. It helps ensure uniform data entry and analysis for reporting and regulatory submissions.
8. What is the difference between expected and unexpected adverse reactions?
Answer:
- Expected ADR: Listed in the product’s reference safety information (e.g., Investigator’s Brochure or SmPC).
- Unexpected ADR: Not listed or differs in nature/severity from what is in the reference safety document.
9. How do you handle duplicate cases in safety databases?
Answer:
By checking unique identifiers (patient initials, dates, reporter details, event type, and drug). If duplicates are found, they are merged to retain the most complete and recent data while maintaining traceability.
⚖️ Regulatory Knowledge
10. What is EudraVigilance and how does it relate to the EMA?
Answer:
EudraVigilance is the European database managed by the European Medicines Agency (EMA) for collecting and analyzing suspected adverse reactions for medicines authorized in the European Economic Area (EEA). It supports signal detection and regulatory decisions within the EU.
11. What is the difference between CIOMS and FDA MedWatch forms?
Answer:
- CIOMS form: Used internationally for reporting adverse drug reactions, especially in clinical trials.
- FDA MedWatch form (Form 3500A): Used in the U.S. for post-marketing and clinical trial safety reporting to the FDA.
The format and data fields are similar but tailored to regional regulatory requirements.
12. Can you explain the EU Clinical Trials Regulation (EU CTR)?
Answer:
The EU CTR (Regulation EU No 536/2014) harmonizes clinical trial processes across EU member states. It mandates transparent reporting, central submission via the Clinical Trials Information System (CTIS), and improved safety monitoring and communication.
13. What are the timelines for expedited reporting of serious adverse events?
Answer:
- Fatal or life-threatening cases: Within 7 calendar days (with follow-up in 8 additional days).
- Other serious cases: Within 15 calendar days from initial awareness.
Timelines can vary slightly based on regional regulations.
🧪 Signal Detection & Risk Management
14. What is signal detection in pharmacovigilance?
Answer:
Signal detection involves identifying new or changed associations between a drug and an adverse event, using data analysis, statistical methods, and clinical judgment. Signals may arise from spontaneous reports, literature, or studies.
15. How do you assess causality in adverse event reports?
Answer:
Causality is assessed using criteria like:
- Temporal relationship (timing of event vs. drug use)
- Dechallenge/rechallenge outcomes
- Biological plausibility
- Alternative causes
Tools like the WHO-UMC scale or Naranjo Algorithm are often used.
16. What is a Risk Management Plan (RMP)?
Answer:
An RMP is a regulatory document describing a product’s known and potential risks, risk minimization measures, and plans for post-marketing surveillance. It ensures ongoing evaluation of drug safety throughout its lifecycle.
17. How do you use disproportionality analysis in signal detection?
Answer:
Disproportionality analysis statistically compares the frequency of a specific adverse event for one drug vs. all others (e.g., Reporting Odds Ratio, Proportional Reporting Ratio). It helps identify signals that occur more often than expected.
💻 Tools & Systems
18. Which safety databases have you worked with?
Answer:
Common databases include:
- Oracle Argus
- ARISg
- VigiFlow (WHO)
- SafetyEasy or Empirica Signal
Experience typically involves case entry, coding with MedDRA, narrative writing, and report submission.
19. How do you ensure data quality and compliance in case processing?
Answer:
- Follow SOPs and regulatory guidelines.
- Perform QC checks for accuracy, completeness, and consistency.
- Use validated systems and audit trails.
- Document everything clearly and meet reporting timelines.
20. What is the role of automation and AI in pharmacovigilance?
Answer:
AI and automation help with:
- Case triage and duplicate detection.
- Auto-coding using NLP.
- Signal detection using machine learning.
- Efficiency improvement and error reduction while maintaining compliance.
🧩 Scenario-Based & Behavioral Questions
21. Describe a time you identified a potential safety signal. What did you do?
Sample Answer:
In a previous project, I noticed repeated cases of the same event for a specific batch. I discussed it with my team lead, verified the data in the database, and prepared a line listing. The case cluster was escalated to medical review, which led to further investigation and reporting to regulatory authorities.
22. How do you prioritize tasks when handling multiple cases?
Answer:
I prioritize based on case seriousness, due dates, and regulatory timelines. I usually handle expedited cases first (7-day, 15-day), then non-serious ones. I also track deadlines using workflow tools or spreadsheets to ensure no delays.
23. How do you stay updated with global regulatory changes?
Answer:
By regularly reviewing:
- EMA, FDA, and MHRA websites
- WHO and ICH updates
- Attending PV webinars and trainings
- Reading newsletters like Regulatory Affairs Professionals Society (RAPS) or DIA publications.
24. How would you handle a situation where a case lacks critical information?
Answer:
I would perform a follow-up request to the reporter for missing details (e.g., medical history, dates, dosage). Until then, I document all available information, mark fields as “unknown,” and keep the case in a “follow-up required” status while ensuring compliance with submission timelines.