PSMF in Pharmacovigilance: Beginner’s Guide for 2026

The Pharmacovigilance System Master File (PSMF) explains how a company protects patients through structured safety work. It shows regulators the people, processes, and systems behind every safety decision. In this beginner’s guide, you learn what a PSMF in pharmacovigilance includes, who needs it, and how it supports inspections and compliance.