Pharmacovigilance System Master File (PSMF)

Marketing authorization holders are required to establish or to have access to a pharmacovigilance (PV) system that covers all PV activities. A PV system needs to clearly show the organization of the roles and responsibilities involved and include the activities of collection and processing of safety information, reporting to regulatory authorities, signal detection, and risk minimization. These PV activities and processes need to be described in standard operating procedure (SOP) documents that become part of the PV Quality Management System (QMS).

Since 2012, a detailed document, titled the Pharmacovigilance System Master File (PSMF), has been required in the European Union (EU)/European Economic Area (EEA) to describe a company’s PV system and its associated QMS. The PSMF must indicate all PV activities and stakeholders involved, and it must be continuously updated. Several other countries around the world also require a PSMF or a similar document, which may have country-specific requirements.

At Med Communications we understand that the PSMF can be a challenging document to create and maintain and that there are no workarounds. Our PV professionals have the tools, templates, and accelerators to quickly and efficiently help our clients establish a complete and compliant PSMF. We take on this responsibility for our clients, working closely with them to collect the required information, write the main document and annexes, and maintain the PSMF over time within defined review cycles. We develop the PSMF based on specific local requirements, thereby helping our clients expand their businesses.