Pharmacovigilance interview questions

6 questions, each with a worked answer

1. 1 What information is needed for a valid individual case safety report? Fundamentals Concept
2. 2 How do an adverse event and an adverse drug reaction differ? Fundamentals Concept
3. 3 How are severity, seriousness and expectedness different? Fundamentals Scenario
4. 4 What evidence is useful in causality assessment? Intermediate Concept
5. 5 How can duplicate safety reports distort signal detection? Advanced Scenario
6. 6 How would you manage a safety report with missing mandatory information? Intermediate Scenario

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