Achieve Greater Efficiencies with a Modern and Unified Safety Solution

This video provides an in-depth exploration of streamlining pharmacovigilance (PV) operations through the use of the Veeva Vault Safety Suite, a unified safety solution designed to consolidate disparate safety activities into a single, compliant platform. The presentation emphasizes how integrating case processing, aggregate reporting, ad hoc reporting, signal management, and safety document management within one Vault environment eliminates the need for multiple third-party tools, reducing validation overhead and improving operational efficiency. The speaker demonstrates the system's core functionalities, starting with the user's home screen, which acts as a centralized task management hub for reviewing and approving cases, managing outbound submissions, updating safety documents (like PSMF and PVA agreements), and tracking aggregate report statuses.

The progression of the demonstration follows the typical PV workflow, beginning with the Inbox area, where all inbound sources of information are accumulated for initial review and validation before being promoted to a formal case. Veeva Vault Safety supports native ingestion via a built-in Gateway for standard E2B R2, R3, and E2B+ formats, alongside automated extraction of document content. The core Cases menu is where triage, data entry, QC, medical review, and final approval activities occur. The system is highly configurable, offering customizable workflows and page layouts, and crucially supports localization for both intake and outbound reporting, enabling compliance with jurisdiction-specific requirements, such as preparing a case for local submission in Japanese to the PMDA.

A significant portion of the video focuses on regulatory compliance and reporting efficiency. The Transmissions area manages the distribution of both business partner and health authority Individual Case Safety Reports (ICSRs). A key value proposition highlighted is the inclusion of a native outbound Gateway within the standard Vault Safety application, eliminating the need for separate, costly, and time-consuming validation of third-party transmission tools. This gateway supports various formats, including E2B R2/R3+, MedDRA, and CIMS outputs. Furthermore, the suite supports the generation of standard aggregate reports (DSUR, PBRER, PSUR, PADER), uniquely integrating the report generation process with the overall document management and collaboration workflow necessary for regulatory submission readiness.

Finally, the presentation showcases the platform's analytical and document management capabilities. The system leverages the real-time, native Vault platform reporting engine to provide diverse visualizations of PV data, covering intake activity, transmission status, case workflow progress, and aggregate report status. These reports are highly configurable using point-and-click tools, allowing users to easily manipulate and export tabular outputs or line listings. The Vault Safety Docs Library is presented as a critical differentiator, bringing the entire document creation, review, and approval lifecycle for PV-related content (like PSMF, Signal Management documents, and PVA agreements) directly into the validated Vault environment, replacing the need for non-validated SharePoint sites or other third-party document management systems.

Key Takeaways: • Unified PV Operations: Veeva Vault Safety consolidates all pharmacovigilance activities—case processing, aggregate reporting, signal management, and safety document management—into a single, unified Vault environment, significantly reducing system fragmentation and overhead. • Native Regulatory Gateway: The system includes a native inbound and outbound regulatory Gateway supporting E2B R2, R3, and E2B+ formats as standard, eliminating the need for pharmaceutical companies to purchase and validate separate, costly third-party transmission tools. • Streamlined Case Triage and Processing: The Inbox area centralizes all inbound safety data sources, facilitating preliminary review and validation before promotion to a formal case, while configurable workflows support efficient triage, data entry, QC, and medical review. • Localization for Global Compliance: Vault Safety supports local intake and outbound reporting, allowing users to handle cases and prepare submissions in localized formats (e.g., Japanese for PMDA), ensuring adherence to specific country-level regulatory requirements. • Integrated Aggregate Reporting: The platform supports the generation of standard aggregate reports (DSUR, PSUR, PBRER) and, critically, marries the report generation output with the document management and collaboration workflow required to finalize the report for regulatory submission. • Real-Time Business Intelligence: Utilizing the native Vault platform reporting capability, users gain real-time analytics and visualizations across all PV activities, including intake volume, transmission success rates, case workflow bottlenecks, and the status of in-flight aggregate reports. • Consolidated Document Management (Vault Safety Docs): The Docs Library replaces non-validated third-party systems (like SharePoint or Documentum) for PV document lifecycle management, bringing critical documents (PSMF, PVA agreements, Signal Management files) into the validated, compliant Vault ecosystem. • Configurable User Experience: The interface features configurable workflows and page layouts, making the system clean, easy for users to adapt to, and customizable to specific organizational processes within the regulated environment. • Focus on Compliance and Validation: By integrating core functions and providing a native gateway and document library, the solution minimizes the validation burden typically associated with integrating multiple systems in a GxP environment.

Tools/Resources Mentioned:

• Veeva Vault Safety Suite
• Veeva Vault Safety Docs Library
• Veeva Native Gateway (for E2B transmission)

Key Concepts:

• Pharmacovigilance (PV): The process of monitoring and assessing the safety of medicines.
• E2B R2/R3/E2B+: International standards for the electronic transmission of Individual Case Safety Reports (ICSRs).
• ICSR: Individual Case Safety Report, a report detailing a suspected adverse drug reaction.
• Aggregate Reporting: Periodic safety reporting required by health authorities, including:
  • DSUR: Development Safety Update Report
  • PBRER: Periodic Benefit-Risk Evaluation Report
  • PSUR: Periodic Safety Update Report
  • PADER: Periodic Adverse Drug Experience Report
• PSMF (Pharmacovigilance System Master File): A detailed description of the pharmacovigilance system used by the marketing authorization holder.
• PVA Agreement (Pharmacovigilance Agreement): Contractual agreements defining PV responsibilities between partners.
• Signal Management: The process of detecting, validating, assessing, and prioritizing signals from safety data.