Increase efficiency and gain oversight of pharmacovigilance agreement obligations

Veeva SafetyDocs enables more efficient management of pharmacovigilance agreements (PVAs) and safety data exchange agreements (SDEAs) and provides oversight of PVA/SDEA obligations.

With secure access and customizable workflows, Veeva SafetyDocs makes it easier to collaborate with external partners, manage multiple PVAs/SDEAs globally, and track obligations for improved compliance.

Business Benefits

  • Improve partner adherence.
    Gain oversight of partners and PVA obligations with task workflows and customizable reports and dashboards. Efficiently monitor activities for timely completion to reduce compliance risk.
  • Efficient PVA lifecycle management.
    Centralize PVA documents and workflows in a single system to manage all of your PVAs and SDEAs from authoring through termination.
  • Always use the right version.
    Automated version control ensures the correct PVA version is always used and improves inspection readiness.

Features

  • Automated Obligation Scheduling
    Automate recurring PVA activities to support real- time reporting and reduce manual effort.
  • Reports and Dashboards
    Track operational metrics to determine the status of PVA obligations, as well as oversight of partner activities and compliance.
  • Real-time Document Distribution
    Securely share documents with partners via email or a Vault workflow and track their activity, including receipt and acknowledgment.
  • Configurable Workflows
    Automatically generate tasks for external partners to ensure agreed-upon obligations are completed timely.
  • Version Control
    Automate versioning and easily compare documents to previous versions to see how the content was changed.
  • User Access Management
    Set up secure user access roles to define what content users are allowed to view or edit and what activities they can complete.
  • Automated Notifications
    Receive automatic alerts when a pharmacovigilance agreement is due to expire.
  • Template Management
    Create and store PVA templates to speed up the time to draft new pharmacovigilance agreements.

Watch demo to see how to improve oversight and tracking of PVAs.