12 Pharmacovigilance Interview Questions With Answers
Practise pharmacovigilance interviews on case intake, follow-up, duplicates, narratives, quality checks and safety escalation, with official references.
Pharmacovigilance interviews can cover case processing, medical review, literature surveillance or signal work. Match your preparation to the advertised responsibility. These practice questions explain the reasoning behind a workflow; reporting rules and deadlines must be checked for the relevant product, jurisdiction and current procedure.
Prepare a specific example
Prepare a fictional case-processing walkthrough showing receipt, validation, missing information, review and follow-up. Do not include real patient data. Explain which decisions you could make in your role and which required medical or regulatory review.
Interview questions & answers
Foundations
1.What is pharmacovigilance?
It is the work of identifying, assessing and reducing medicine- or vaccine-related safety problems. It continues beyond initial approval because wider and longer use can reveal information not established during trials. In an interview, connect the definition to the role: accurate case intake, review and escalation contribute different parts of the safety process.
Case intake
1.What information do you check when a possible safety case arrives?
For EU ICSR validation, Module VI identifies an identifiable reporter, identifiable patient, suspected medicinal product and suspected adverse reaction as minimum elements. Check the applicable current guidance and local process, record receipt and preserve the source. Missing information calls for appropriate follow-up; it is not a reason to discard the report silently.
2.What would you do with an incomplete report?
Record the information received and its source, identify the missing elements and follow the approved follow-up process. Keep the original information distinguishable from later additions. Escalate uncertainty about validity or urgency to the appropriate reviewer rather than filling gaps with assumptions.
3.How would you investigate a possible duplicate case?
Compare the available patient characteristics, product, event, dates, reporter and source identifiers using the approved duplicate-review process. Similar details are a reason to investigate, not proof of duplication. Preserve traceability when records are linked or merged and document the reviewer’s decision.
Case quality
1.What belongs in a clear case narrative?
Present the relevant events in a readable chronology, distinguish the reported facts from assessments and explain missing or conflicting information. Keep dates, product details and outcome consistent with the structured fields. A polished narrative should not make an uncertain causal relationship sound established.
2.What if the source and database show different dates?
Return to the original source and any follow-up, identify whether the discrepancy came from transcription, format or conflicting reports, then use the approved correction process. Preserve the audit trail and obtain review where required. Do not choose the date that makes the case appear on time.
3.How do you approach terminology coding?
Use the required terminology version and coding conventions, preserving the reporter’s meaning without adding an unsupported diagnosis. If the source is ambiguous, seek the appropriate clarification or coding review. Describe your actual level of experience with the system instead of claiming that a software suggestion removes the need for judgement.
Escalation
1.What if you discover a report was received earlier than recorded?
Preserve the evidence of the earlier receipt and notify the responsible safety lead promptly. Correct the record through the approved process and assess any reporting impact with the relevant specialist. Document the cause and follow-up action. Do not change dates merely to make a timeline appear compliant.
Assessment
1.Does a reported event prove that a medicine caused it?
No. A report provides information for assessment; timing alone does not establish causation. Relevant context may include other medicines, illness and the course of the event. Explain which assessment belongs to your role and when medical review is needed. Do not turn a suspected association into a confirmed claim.
2.How is a potential safety signal different from a confirmed risk?
A potential signal is information that warrants further evaluation of a possible safety issue. It is not automatically proof of causation or a final regulatory conclusion. In an interview, explain how evidence would be reviewed and escalated under the organisation’s signal-management process rather than deciding from a report count alone.
Professional practice
1.How would you protect patient information during training or an interview?
Use fictional or appropriately authorised de-identified examples and the organisation’s approved systems. Do not export case screenshots or patient narratives into personal notes or interview slides. Describe the process and your contribution without revealing identities or details that could reasonably identify the person.
2.How do you keep regulatory knowledge current?
Check the applicable authority’s current guidance and the organisation’s controlled procedures, then complete required training when the process changes. EMA notes that recent ICH guidance affects parts of existing GVP material. Name the jurisdiction and version you used instead of treating an old interview answer as a permanent rule.
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