Pharmacovigilance (GVP)
Post-market safety surveillance, signal management, and timely case reporting.
What a domain score is not
A domain is one of the axes SPEQ’s assessment scores, on SPEQ’s own five-stage progression. It is a labelled synthesis, not the FDA’s Quality Management Maturity rating, and a score here is a self-assessment — nobody but you has rated your organization.
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 mature version of pharmacovigilance is a system that knows what it knows. Low maturity is case processing: reports arrive, are coded, and are submitted on time, and the safety profile is reviewed when a period ends. High maturity is a system with an accurate description of itself, oversight of every party that collects cases on its behalf, and signal detection that looks at the series rather than the case. The clearest divide is day zero — whether awareness anywhere in the organisation reliably reaches the safety function.
- Fix day zero. Map every route by which the organisation could first learn of an event — medical information, sales, complaints, affiliates, vendors, social channels — and measure the lag from each to the safety database.
- Keep the description of the system live. It is the first document an inspector compares against what they find, and it drifts silently whenever a site, a vendor or a process changes.
- Instrument vendor and affiliate oversight. Contracts and arriving reports do not tell you whether cases are being collected; reconciliation does.
- Make signal detection look across cases and across sources on a defined cadence, with the decision recorded — including the decision that a series is not a signal.
Distribution of day-zero lag by source is the most diagnostic measure in this domain, far more than on-time submission rate — a system can be entirely on time from the moment it hears and still be late. Then: reconciliation discrepancies with partners, and the time from signal detection to a documented evaluation decision.
The observable behaviours that place a site at each level — what a practitioner or inspector would actually see — and the concrete move that carries it to the next.
- ·Case intake is inconsistent; some events are missed
- ·Reporting-clock compliance is uncertain
- ·No systematic signal detection
TO ADVANCE →Establish case-processing SOPs and reliable intake with reporting-timeline control.
- ·Cases are processed and submitted on time
- ·Signal detection is manual and ad hoc
- ·The PSMF exists but lags reality
TO ADVANCE →Stand up systematic signal management and keep the PSMF current.
- ·Signals are detected, evaluated, and actioned on a defined process
- ·Reporting-clock compliance is monitored
- ·The PSMF reflects the actual system
TO ADVANCE →Add signal and safety metrics so benefit-risk is managed proactively.
- ·Signal and case metrics are trended and reviewed
- ·Benefit-risk is actively managed, not just reported
- ·Quality of case data is measured and improved
TO ADVANCE →Move toward proactive safety science — anticipate risk from real-world and trial data.
- ·Predictive analytics on real-world and trial safety data
- ·Proactive benefit-risk management across the lifecycle
- ·Safety insight informs development and labelling early
- An individual case from receipt to submission, within the regulatory clock, fully documented
- A signal-management record: detection, evaluation, and the action or justification for none
- The Pharmacovigilance System Master File (PSMF) and evidence it is current
Want the specific artifacts that move your score up? The Comprehensive assessment turns your domain scores into a prioritised, personalised remediation plan.
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.