Veeva Safety Suite Solution Brief

Veeva Safety Suite streamlines pharmacovigilance (PV) operations and enables better-informed safety decisions— from intake to insight.

Unified solution that brings together global case processing, signal detection, advanced reporting, and safety content and process management on a single validated cloud platform.

Automates flow of safety information across clinical and post-market activities with seamless connections to Veeva EDC, Veeva Quality, and Veeva MedInquiry.

With a common data foundation and end-to-end processes, Veeva Safety Suite reduces operational overhead and maintains traceability from insight back to the source. PV teams gain timely, reliable information to evaluate safety risks and can more easily support inspection readiness.

Benefits

• Increase operational efficiency

  Reduce reconciliation and data siloes, eliminate manual workflows, and improve data quality.

• Enable better-informed safety decisions

  Access timely, reliable, and more comprehensive data to support medical review, signal evaluation, and risk management.

• Easily support ongoing compliance

  Stay current with global regulations through regular updates to the safety solution.

• Strengthen inspection readiness

  Maintain a single trusted source of safety data with traceability back to the source.

• Reduce total cost of ownership (TCO)

  Simplify maintenance and lower IT overhead with a single platform for PV operations.

Veeva Safety Suite

Veeva Safety

Case Intake, Processing, and Submissions
Globally manage the intake, processing, and submission of adverse events for clinical and post-marketed products, including drug, biologic, vaccine, device, and combination products. Built-in gateway connections and reporting rules streamline ICSR submissions to health authorities (including FDA, EMA, PMDA, NMPA) and distribution to partners.

Veeva SafetyDocs

Safety Process and Content Management
Centrally manage regulated safety- and pharmacovigilance-related content and processes, including pharmacovigilance system master files (PSMF), pharmacovigilance agreements (PVAs), risk management plans (RMPs) and additional risk minimization measures (aRMMs), aggregate reports, and safety signal investigations.

Veeva Safety Workbench

Advanced Querying and Regulatory Reports
Run advanced reports and analytics for large volumes of data and complex analyses. Ad-hoc reports and dashboards provide the flexibility to generate complex formats, outputs, and deep analytics insights.

Veeva Safety Signal

Signal Detection and Notification
Detects signals using statistical methods on data from Veeva Safety and standard industry sources, including FAERS, VAERS, and EVDAS. Signal detection activities can be tracked and automated using alerts and workflows.

Hear how UCB is gaining efficiency and streamlining global compliance with a unified safety system.