Why Accountability and Documentation Are Their Own Discipline

Every module up to this point in this course has been about doing pharmacovigilance work correctly — coding a case accurately, writing an objective narrative, assessing causality defensibly, detecting a real signal, compiling an honest aggregate report, planning risk minimisation that actually works, and running the database all of that lives inside. This module is about something related but genuinely distinct: who is legally accountable for all of that happening correctly, and what single document describes the system well enough for a regulator to understand it without ever visiting the company.

That distinction matters because a PV system can be doing excellent individual-case work and still fail an inspection, if it can’t demonstrate that the excellence is systematic rather than incidental — that there’s a named person accountable for it, and a document describing how it all fits together in enough detail to be genuinely useful to someone seeing it for the first time. This is the layer of pharmacovigilance that sits above individual case work and makes the whole system legible and auditable at scale.

Two things anchor this module. The QPPV — or PVOIC in India, or the equivalent named role in whichever region a company operates — is one specific, identifiable person who carries personal legal accountability for the PV system, not a diffuse departmental responsibility. The PSMF (Pharmacovigilance System Master File) is the single document that describes that entire system in enough detail for a regulator to understand it without visiting the company at all — and it’s the very first document an inspector asks to see.

This module works through both in that order — the accountable person, then the document describing the system — before closing with how that document is kept genuinely current rather than becoming a description of a system that no longer exists. Module 12 picks up directly from there, covering the quality system and CAPA process that keep the PSMF’s description honest between inspections.