Veeva Safety Signal is a modern application with the ability to detect new, unexpected adverse events or changes in an existing adverse event to a medicinal product. This analysis can occur in postmarketing or during clinical trials. Veeva Safety Signal enables tracking safety risks with the medicinal product and investigating Product-Event Combinations (PECs).
Note: You must also have the Veeva Safety application set up to use Veeva Safety Signal.
Compliance with Multiple Data Sources
Veeva Safety Signal can access PEC data from various sources for signal detection. These sources include pharmacovigilance (PV) data from Veeva Safety, literature data from Veeva SafetyDocs, and data from other health authorities (for example, EVDAS from the EMA).
Configurable Signal Alerts
Various statistical calculations and scores are available for detecting PECs. Your organization’s business rules inform the threshold for signal detection.
Periodic and Ad-Hoc Signal Reporting
Veeva Safety Signal performs signal detection periodically. Signal detection can also be triggered manually for ad-hoc reporting.
Integration with Safety, Safety Workbench & SafetyDocs
A Veeva Safety license is required in addition to a Veeva Safety Signal license in order to perform signal detection on PV data. Optionally, Veeva Safety Signal can be used alongside Veeva SafetyDocs and Veeva Safety Workbench. Following signal detection, users can seamlessly transition to the signal management process using Veeva SafetyDocs.
For more information on licensing other Veeva Safety Suite applications, contact your Veeva Representative.
Recurring Data Sync from Veeva Safety
Vault performs a reliable, daily extract, transfer, and load (ETL) of safety data from Veeva Safety to Veeva Safety Signal. This data sync improves efficiency and consistency and reduces the need for third-party solutions. Signal extracts only object data from Veeva Safety. As a result, certain data types and metadata are not available in Signal:
- Documents and workflows
- Picklists
- Tasks, Vault configuration, and intake data (for example, Inbox Items)
See a complete list of Safety objects excluded from the data sync.
The daily transfer typically occurs at 1:00 AM, after the Direct Data API file is available. By default, your Vault follows the Vault Time Zone, but may be configured to use Coordinated Universal Time (UTC). If the Direct Data API file is unavailable for any reason, Vault attempts to synchronize the data from Veeva Safety every hour until it succeeds. If the data sync does not succeed after six hours, the job fails and Vault sends error notifications to the appropriate recipients.Â