The Pharmacovigilance System Master File (PSMF) is a legal requirement in the European Union (EU). A PSMF shall describe the pharmacovigilance (PV) system for one or more medicinal products of a marketing authorization holder (MAH) and support/document its compliance thus managing and improving the PV system.
Risk Management Services
PRA Health Sciences (PRA) experts have significant experience providing end-to-end risk management services. Our integrated global teams identify…
Sponsor and CRO Pharmacovigilance Alliances
Outsourcing pharmacovigilance activities is a standard business practice in a continuously expanding market segment. In the past, outsourced safety…
Pharmacovigilance & Patient Safety
Clinical trial participants help us speed breakthroughs in modern drug development. Our job is to protect them.