Pharmacovigilance and Drug Safety
What this domain tests
This domain tests whether you recognise a safety case in any setting and know the reporting mechanics: definitions, minimum criteria, timelines, aggregate reports and risk management.
Core rules
- An adverse event is any untoward medical occurrence; an adverse drug reaction is one with reasonable causal relationship. Seriousness means death, life-threatening, hospitalisation or prolongation, persistent disability, congenital anomaly, or an important medical event.
- A valid case needs four elements: identifiable patient, identifiable reporter, suspect product, and the event. Do not delay reporting to complete them.
- Timelines: fatal or life-threatening unexpected suspected adverse reactions within 7 days with an 8-day follow-up; other SUSARs within 15 days; DSUR annually; PSUR/PBRER per the EU schedule; PADER and annual reports in the US.
- Activities: individual case intake and MedDRA coding, causality assessment, signal detection and evaluation, risk management plans, REMS/RiskMAP, and labelling updates.
- Everyone is a reporter: field medical, medical information and commercial staff forward any mention of an adverse event to pharmacovigilance within 24 hours.
Worked example
During an advisory board a specialist remarks that one of their patients developed angioedema after the first infusion. The MSL does not assess causality, does not decide it is "probably the underlying disease", and does not wait for the meeting minutes. They capture patient identifiers available, reporter details, product and event, and send it to pharmacovigilance the same day.
Traps that cost marks
- Reporting only serious events; non-serious events are also reportable.
- Overlooking special situations: pregnancy, overdose, medication error, lack of efficacy, off-label use.
- Waiting for confirmation before escalating an event heard second-hand.