Pharmacovigilance (GVP)
Post-market safety surveillance, signal management, and timely case reporting.
Post-market safety is a legal obligation, not a courtesy. A stale Pharmacovigilance System Master File, an unclear or unsupported QPPV, and missed ICSR timelines are among the most cited pharmacovigilance inspection findings — and the ones most likely to signal a system that is not actually watching.
The observable evidence a practitioner — or an inspector — would expect at each maturity level. Drawn from the assessment questions themselves.
How mature is your pharmacovigilance system and its master file?
Pharmacovigilance handled reactively; no maintained PSMF
PSMF exists but is updated infrequently; the QPPV role is unclear
Maintained PSMF, a defined QPPV, and documented PV processes per EU GVP
PSMF continuously current with PV system performance metrics and audits
Continuously current PSMF with real-time PV system-performance analytics and predictive audit and inspection management
How is adverse-event / ICSR reporting managed?
Cases reported manually; timelines are occasionally missed
A reporting SOP exists; reconciliation with the safety database is periodic
Structured ICSR management meeting expedited timelines (E2B(R3) via FAERS/EudraVigilance)
Automated case intake, timeline tracking, and signal management per GVP Module IX
Automated end-to-end case management with predictive signal detection and continuous timeline-compliance analytics per GVP Module IX
- ›PSMF not maintained or current; the QPPV role undefined or unsupported.
- ›ICSR and expedited-reporting timelines missed (E2B(R3); EU GVP Module VI).
- ›Signal management not documented, or signals not acted upon (GVP Module IX).
- ›Reconciliation gaps between intake sources and the safety database.