It supports global and domestic adverse event management for drugs, biologics, vaccines, devices, and combination products, all within a single system.

Key Features:

• Comprehensive Adverse Event Management:
  • Intake and Processing: Facilitates the intake and processing of adverse events, ensuring efficient and accurate data capture.
  • Submission Management: Streamlines the submission of cases to health authorities and partners through built-in gateway connections and reporting rules.
• Global Oversight:
  • Real-Time Reporting: Provides real-time reports and dashboards for global and domestic adverse events, offering comprehensive oversight.
  • Central Coding Dictionary Management: Automates updates for MedDRA, WHODrug, and EDQM dictionaries, ensuring consistency and compliance.
• Integration and Connectivity:
  • Vault Connections: Seamlessly integrates with other Veeva Vault applications, such as Clinical, Quality, and Regulatory, to enable end-to-end safety processes and data sharing.
  • SafetyDocs Integration: Manages safety-related content and processes, including pharmacovigilance master files, agreements, risk management plans, and safety signal investigations.
• Efficiency and Automation:
  • Automated Workflows: Enhances process efficiencies from intake through case processing and submissions, reducing manual effort and increasing accuracy.
  • Continuous Updates: Supports new regulatory requirements and product innovations with regular updates, ensuring the system remains current.
• User-Friendly Interface:
  • Intuitive Design: Features a user-friendly interface that simplifies the management of safety data and processes, making it accessible for all users.
  • Training and Support: Provides comprehensive training and support resources to help users maximize the platform’s capabilities.

Benefits

• Improved Safety Oversight: Enhances the ability to monitor and manage adverse events, improving overall patient safety.
• Increased Efficiency: Automates key processes, reducing administrative burden and speeding up case processing times.
• Enhanced Compliance: Ensures compliance with global regulatory requirements through automated updates and robust reporting capabilities.
• Better Data Management: Centralizes safety data, providing a single source of truth for all adverse event information.