Veeva Safety Signal

Veeva Safety Signal is a comprehensive solution for signal detection, validation, and management. Harnessing the power of Amazon Redshift, it reloads the complete Safety dataset every night, ensuring data is fast, consistent, and reliable. Common data sources such as FAERS, VAERS, and EVDAS are routinely curated and integrated into the system.

Users can either schedule or carry out ad-hoc signal calculations using widely accepted disproportionality methods to detect, assess, and manage potential safety signals. The system offers configurable alerts and automated workflows to prioritize the analysis of statistically significant findings.

Moreover, signal detection can be configured directly within Veeva Safety during the case processing stage so that alerts are generated when cases meet predefined key criteria.

Features and Benefits

• Fast Signal Detection: Automatically aggregates data and extracts signals from multiple sources including FAERS, VAERS, EVDAS, and Veeva Safety.
• Greater Business Alignment: Flexible and configurable workflows enable seamless alignment with signal management processes.
• Streamlined Compliance: Offers complete visibility and traceability from the initial signal to the originating safety cases.
• End-to-End Management: Integrated with Veeva Safety and Veeva SafetyDocs for comprehensive signal detection and risk management coverage.