Safety Reporting and Pharmacovigilance
Pharmacovigilance is the science of detecting, assessing, and preventing adverse effects. Candidates must understand adverse event (AE) and serious adverse event (SAE) definitions, severity versus seriousness, causality assessment, expectedness against reference safety information, and expedited reporting timelines for suspected unexpected serious adverse reactions (SUSARs).
Core concepts include seriousness criteria (death, life-threatening, hospitalization, disability, congenital anomaly, important medical event), sponsor and investigator reporting responsibilities, DSMB/DMC oversight, periodic safety reports (e.g., DSUR, PSUR), pregnancy reporting, and safety database coding. Know that the investigator reports SAEs to the sponsor promptly (often within 24 hours per protocol), and the sponsor assesses expectedness and reports SUSARs to regulators and IRBs within defined timelines.
Traps: equating severity with seriousness (a severe headache is not necessarily serious; a mild hospitalization is); assuming all AEs are reported to regulators (only SUSARs are expedited); and forgetting that expectedness is judged against the current reference safety information. Another frequent trap is causality - the investigator's assessment governs for reporting, even if the sponsor disagrees.
Rule of thumb: expedited reporting requires all four: suspected, unexpected, serious, and an adverse reaction - miss one and it is not a SUSAR.
Worked example: A subject is hospitalized with a rash not listed in the investigator's brochure and assessed as related. This is serious, unexpected, and suspected - a SUSAR requiring expedited reporting.