What this round covers
- ICSR intake and triage
- Seriousness, causality and expectedness
- E2B and reporting timelines
- Signal detection and validation
- PSUR, PBRER and DSUR
10 Pharmacovigilance interview questions with answers
- Q1BasicsBeginner
Pharmacovigilance is defined by WHO as the science relating to:
Model answer: PV covers the full lifecycle of detecting, assessing, understanding and preventing adverse effects.
- Patient safety focus
- Lifecycle activity
- Regulatory obligation
- Q2BasicsBeginner
An adverse event differs from an adverse drug reaction because an AE:
Model answer: An AE is any untoward medical occurrence; an ADR implies at least a reasonable causal relationship.
- Causality assessment
- Temporal relationship
- Reporting implications
- Q3SeriousnessBeginner
Which of the following makes a case serious?
Model answer: Seriousness criteria include death, life-threatening, hospitalisation, disability, congenital anomaly and medically important events.
- Six criteria
- Medically important list
- Expedited timelines
- Q4ICSRBeginner
A valid ICSR requires minimum criteria of:
Model answer: All four elements must be present for a case to be valid and reportable.
- Follow-up for missing data
- Non-valid case handling
- Documentation
- Q5SUSARIntermediate
Serious unexpected suspected adverse reactions from clinical trials must be reported within:
Model answer: Fatal/life-threatening SUSARs are reported within 7 days, others within 15 days.
- Clock start at day 0
- Follow-up reports
- Regulatory portals
- Q6TimelinesIntermediate
Day 0 for expedited reporting is:
Model answer: The clock starts when any employee of the company first becomes aware of a valid case.
- Awareness definition
- Affiliate obligations
- Documentation of receipt
- Q7TimelinesIntermediate
Expedited reporting of post-marketing serious unexpected ADRs is generally within:
Model answer: Serious unexpected post-marketing cases are reported within 15 calendar days.
- Expectedness vs RSI
- Regional variations
- Follow-up reporting
- Q8ExpectednessAdvanced
Expectedness of a reaction is determined against:
Model answer: Expectedness is assessed against the applicable reference safety information.
- RSI version control
- Trial vs marketed product
- Impact on reporting
- Q9CausalityIntermediate
The Naranjo algorithm is used for:
Model answer: Naranjo scores probability of causality (definite, probable, possible, doubtful).
- Dechallenge/rechallenge
- Alternative causes
- Documented rationale
- Q10CausalityIntermediate
WHO-UMC causality categories include:
Model answer: WHO-UMC uses certain, probable/likely, possible, unlikely, conditional and unassessable.
- Temporal plausibility
- Dechallenge
- Other explanations
Rehearse these answers out loud
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