Veeva Safety

Veeva Safety is an individual case safety report (ICSR) management system designed for sponsors and CROs that need to manage the intake, processing, and submission of adverse events for clinical and post-marketed products. It supports drug, biologic, vaccine, device, and combination products, handling both global and domestic cases within a single system.

The platform includes built-in gateway connections and reporting rules to streamline submissions to health authorities and distributions to partners. Central coding dictionary management automates semi-annual updates for MedDRA, WHODrug, and EDQM. Veeva Safety is positioned for biopharma organizations of varying sizes, from emerging biotech to large global enterprises, and has been in a mature status since its 2019 announcement with a customer base in the 51–100 range.

Core Capabilities

• End-to-end ICSR management covering intake, case processing, and regulatory submissions
• Processing and oversight of global and domestic adverse events across drug, biologic, vaccine, device, and combination product types
• Built-in gateway connections and reporting rules for submissions to health authorities and partner distributions
• Central coding dictionary management with automated semi-annual MedDRA, WHODrug, and EDQM updates
• Real-time reports and dashboards providing a global case view and oversight across all cases
• Three product releases per year to support new regulatory requirements and deliver product updates

Veeva AI for Safety

• Case Intake Agent: Automates case intake to support faster and more accurate data extraction, and identifies potential data anomalies
• Case Narrative Agent: Assists with case narratives by correcting grammar, consolidating information, and improving readability

Integrations and Workflow

• Supports process and data sharing between safety and clinical, quality, and regulatory applications through Veeva Connections
• Enables direct connection of clinical data into the safety database, reducing manual data entry
• Integrates with Veeva RIM to support package insert management workflows
• Supports ICSR submissions using the FDA E2B(R3) standard

Veeva Safety is part of the broader Veeva Vault platform ecosystem, which also includes SafetyDocs, Safety Workbench, and Safety Signal modules. The system is used by organizations including Merck and LEO Pharma to consolidate pharmacovigilance operations and improve data control, including in outsourced safety scenarios.