Improve Oversight and Reduce Risk for Adverse Events

This video provides an in-depth demonstration of the analytics and reporting capabilities within Veeva Vault Safety, illustrating how these features are leveraged to enhance oversight of Pharmacovigilance (PV) operations and significantly reduce associated risks. The presenter showcases a sample safety dashboard designed to retrieve and visualize real-time data, emphasizing that all critical PV information—including case intake, processing, ICSR (Individual Case Safety Report) outbound submission, and aggregate reporting—is self-contained within the single Vault Safety environment. This centralization ensures immediate access to operational status and safety trends across the organization.

The dashboard visualization highlights the diversity of data formats available, incorporating intake counts, time-based trends, and detailed workflow status. A critical operational insight demonstrated is the ability to quickly identify bottlenecks, such as a significant bulge in items that have not yet been assigned or picked up for triage. This immediate visibility into workflow backlogs allows workflow managers to proactively ensure adequate resource allocation, preventing delays that could compromise regulatory submission timelines and overall compliance.

Beyond operational metrics, the demonstration focuses heavily on the safety profile of products. The system visualizes data to identify common adverse event offenders, serious event terms, and demographic data, allowing users to determine if a safety risk is affecting the worldwide population or if a particular gender or age group is disproportionately afflicted by a product. Furthermore, the analytics track submission performance, providing insights into whether reports are being sent late to health authorities. This functionality helps diagnose underlying issues, whether they stem from internal process failures or technical connectivity problems with downstream regulatory agencies, ensuring comprehensive management of external regulatory obligations.

The core utility of the system is rooted in its native reporting capability, which leverages the standard Veeva Vault platform reporting and analytics suite. This functionality allows users to refine data sets using intuitive, point-and-click configuration. For example, users can quickly filter data to isolate only fatal and life-threatening cases for a specific product. Reports can be customized by easily editing and maneuvering columns to focus on specific data points, such as a particular age group. These reports can be run on demand, scheduled for automated daily, weekly, or monthly distribution, and exported to standard formats like Excel or PDF for offline use and sharing with internal stakeholders or regulatory partners.

Key Takeaways:

• Real-Time PV Data Consolidation: Vault Safety provides immediate oversight of Pharmacovigilance operations by consolidating all critical data—intake, case processing, ICSR submission, and aggregate reporting—into a single, real-time dashboard view within the Vault.
• Operational Risk Mitigation: Dashboards are essential tools for identifying operational bottlenecks, such as significant backlogs in unassigned cases or triage queues, enabling workflow managers to quickly deploy resources and prevent delays that could impact regulatory compliance.
• Proactive Safety Signal Detection: The platform facilitates rapid identification of safety signals by visualizing common adverse event offenders and serious event terms, allowing companies to quickly assess if a safety risk is affecting their global patient population.
• Demographic Safety Analysis: Users can leverage analytics to segment safety data by demographics (e.g., gender or age group), providing targeted insights into which populations may be most affected by a product, informing refined risk management plans.
• Regulatory Submission Compliance Tracking: The system monitors submission timeliness to health authorities, providing crucial insights into potential process failures or connectivity issues that could result in late submissions and regulatory non-compliance.
• User-Friendly Reporting Configuration: The native reporting capability within the Vault platform utilizes point-and-click configuration, allowing non-technical users to easily add filter criteria, refine data sets, and customize column outputs.
• Targeted Case Filtering: Reports can be quickly refined to focus on high-priority data, such as isolating only fatal and life-threatening cases for a specific product, ensuring critical safety information is immediately accessible.
• Flexible Report Automation: Reports can be scheduled to run automatically at required frequencies (daily, weekly, monthly) and delivered directly to stakeholders, ensuring consistent and timely distribution of safety intelligence.
• Offline Data Sharing: The ability to export reports to Excel or PDF formats ensures that detailed safety and compliance data can be easily shared offline with internal teams, partners, or regulatory bodies for review and discussion.
• Comprehensive Process Oversight: The dashboards offer a visualized view covering every part of the PV process, from initial case assignment to final submission, ensuring end-to-end visibility and control over the entire safety lifecycle.

Tools/Resources Mentioned:

• Veeva Vault Safety
• Veeva Vault Platform Reporting and Analytics Suite
• Excel (for report export)
• PDF (for report export)

Key Concepts:

• PV Operations (Pharmacovigilance): The system is designed to manage and oversee the detection, assessment, understanding, and prevention of adverse effects related to pharmaceutical products.
• ICSR (Individual Case Safety Report): A key component of the data managed, representing reports on single adverse event experiences.
• Aggregate Reporting: The system supports the generation and oversight of periodic safety reports compiled from multiple cases over time.
• Triage Backlog: A critical operational metric visualized by the dashboard, representing a queue of unassigned or unprocessed cases that pose a risk to timely case management and submission.