Tag: Pharmacovigilance medical review SOP

SOP for Pharmacovigilance System Master File (PSMF)

SOP for Pharmacovigilance System Master File (PSMF) Pharmacovigilance System Master File Guidelines 1) Purpose The purpose of this SOP is to define the process for creating, maintaining, and updating the Pharmacovigilance System Master File (PSMF) to ensure compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved in the preparation, maintenance, and…

Pharmacovigilance

SOP for Pharmacovigilance Compliance Policy

SOP for Pharmacovigilance Compliance Policy Guidelines for Pharmacovigilance Compliance 1) Purpose The purpose of this SOP is to outline the policies and procedures for ensuring compliance with pharmacovigilance regulations and guidelines to ensure patient safety and regulatory adherence. 2) Scope This SOP applies to all employees involved in pharmacovigilance activities, including the collection, evaluation, and…

Pharmacovigilance