Veeva Vault Safety

Global End-to-End Adverse
Event Management

Adverse event intake, processing, submissions,
and oversight with one global modern solution.

Announced 2019
Status EARLY
Customers 51-100

Veeva Vault Safety is a modern individual case safety report (ICSR) management system that supports intake, processing, and submission of adverse events for clinical and post-marketed products.

Within one system, sponsors and CROs process global and domestic adverse events for drug, biologic, vaccine, device, and combination products. Built-in gateway connections and reporting rules streamline submission management of cases to health authorities and distribution to partners.

Central coding dictionary management automates semi-annual MedDRA, WHODrug, and EDQM updates.

Why Vault Safety

Streamline adverse event management

  • Automate intake through submissions

    Gain ICSR process efficiencies from intake through case processing and submissions.
  • Seamless end-to-end safety processes

    Seamless process and data sharing between safety and clinical, quality, and regulatory applications with Vault Connections.
  • Global case view and oversight

    See and process all global and domestic adverse events / cases and get oversight with real-time reports and dashboards.
  • Always stay current

    Support new regulatory requirements and access product innovation with 3 releases a year.

RESOURCES

Explore and learn

Streamline package insert management: Vault Safety to Vault RIM
Watch video
Improve oversight and data control when outsourcing
Read blog post
Building a safety intelligence unit from the ground up
Read blog post
Transform pharmacovigilance
with Vault Safety
Hear how
Connect safety data across value chain to improve patient safety
Read article
Better control of and access to the safety data
Read case study

Interested in learning more about how Veeva can help?