Veeva SafetyDocs

Regulated Safety Content and Process Management

Veeva SafetyDocs manages pharmacovigilance-related content and processes. It provides solutions for the management of pharmacovigilance system master files (PSMF), pharmacovigilance agreements (PVAs), risk management plans (RMPs) and additional risk minimization measures (aRMMs), aggregate reports, literature articles, and safety signal investigations.

Announced 2019 Status Mature Customers 11-50
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Veeva SafetyDocs
Overview

Regulated Safety Content and Process Management

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Veeva SafetyDocs manages pharmacovigilance-related content and processes. It provides solutions for the management of pharmacovigilance system master files (PSMF), pharmacovigilance agreements (PVAs), risk management plans (RMPs) and additional risk minimization measures (aRMMs), aggregate reports, literature articles, and safety signal investigations.

Why Veeva SafetyDocs

Greater operational efficiency and compliance

Pharmacovigilance System Master File

Centrally manage global and local pharmacovigilance system master files (PSMF) documents.

Pharmacovigilance agreements

Easily track pharmacovigilance agreements (PVAs) and partner data obligations.

Periodic reports

Streamline the assembly and authoring of periodic reports for oversight and compliance.

Other safety content

Store literature articles, risk management plans, and investigate potential safety signals.

“Previously, it took hours to publish a PSMF. Now, I can produce a merged PDF that contains all of the documents in the correct format in less than 30 minutes.”

Brian Baker, PSMF Steward
Moderna
Resources

Explore and Learn

Learn more
Centrally manage pharmacovigilance processes and content
Read white paper
Globalize PSMF management for greater efficiency
Watch webinar
Moderna simplifies with modular PSMF management

Interested in learning more?

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