Veeva SafetyDocs

Veeva SafetyDocs is designed to manage content and processes related to pharmacovigilance in a regulated environment. It offers solutions tailored for maintaining pharmacovigilance system master files (PSMFs), handling pharmacovigilance agreements (PVAs), and organizing risk management plans (RMPs) along with additional risk minimization measures (aRMMs). The system supports effective management of aggregate reports, literature reviews, and ongoing safety signal investigations.

Introducing more efficient safety content handling and process management, SafetyDocs enables organizations to improve their operational efficiency while maintaining compliance with regulatory requirements.

Key Features

• Pharmacovigilance System Master File Management: Facilitate centralized handling of both global and local PSMF documents.
• Pharmacovigilance Agreements: Easily monitor PVAs and manage data responsibilities with partners.
• Periodic Reports: Simplify the compilation and creation of reports to ensure comprehensive oversight and adherence to regulations.
• Safety Content Management: Securely store and evaluate various safety documents and investigate potential safety signals efficiently.

According to Brian Baker, PSMF Steward at Moderna, the time required to publish a PSMF has been drastically reduced, noting the ability to generate a complete PDF with all necessary documents formatted correctly in under 30 minutes.