Vault Safety

Vault Safety is a comprehensive global adverse event management system, designed for the streamlined intake, processing, and submission of individual case safety reports (ICSRs) for both clinical and post-marketed products. This system supports sponsors and CROs in managing worldwide and domestic adverse events across various product types, including drugs, biologics, vaccines, devices, and combination products.

The system features built-in gateway connections alongside reporting rules, facilitating efficient submissions to health authorities and partners. Additionally, it incorporates central coding dictionary management to automate updates for MedDRA, WHODrug, and EDQM.

Key Features:

• Automate the ICSR Process: Enhance the efficiency of adverse event workflows from initial intake through to case processing and submission.
• Seamless Processes and Integration: Ensure continuous data sharing between safety, clinical, quality, and regulatory applications using Veeva Connections.
• Comprehensive Global Oversight: Maintain visibility and control over global and domestic adverse events through real-time reports and dashboards.
• Regular Updates: Gain access to new regulatory requirements and innovations with three annual product releases.

Described by users as intuitive and user-friendly, Veeva Safety empowers organizations to transition from reactive safety measures to a proactive safety intelligence unit.