Real-time Management and
Oversight of Adverse Events

Streamline case processing and management
with a modern safety application in the cloud.


Owning your drug safety solutions for greater control and visibility.
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Veeva Vault Safety

Vault Safety is a drug safety solution for the collection, management, and real-time oversight of adverse
events for more informed decisions and improved compliance.

Benefits

Improve Pharmacovigilance Oversight To Reduce Risk

Real-time reports and dashboards and seamless collaboration with partners provides the necessary visibility for risk mitigation and safety compliance.

Streamline Safety Case Management

Gain efficiencies with a modern drug safety solution built for today’s regulations and best practices.

Stay Current

Access new pharmacovigilance capabilities and the latest regulatory requirements with easy and automatic upgrades.

Unified

A single cloud platform for safety/pharmacovigilance, clinical, regulatory, and quality eliminates silos and drives end-to-end safety processes.

Features

Safety Case Processing

Streamline adverse event management with role-based assignment and routing of safety cases for follow-up and medical review, and intelligent duplicate detection and follow-up.

Single Source of Truth

Improve collaboration, safety data, and pharmacovigilance document quality. Sponsors and CROs leverage the same files across Vault Quality, Vault Clinical, Vault RIM, and Vault MedComms to author, review, and approve safety information and documentation.

Built on Modern Industry Standards

Based on the latest International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Efficacy Guidelines (E2B R2/R3, E2C R2, E2F) and the International Organization for Standardization for the Identification of Medicinal Products (ISO IDMP) standards to align with GxP practices globally.

Dictionary Support

Supports the industry-standard World Health Organization Drug Dictionary (WHODrug C3), the Medical Dictionary for Regulatory Activities (MedDRA), and the Unified Code for Units of Measure (UCUM).

Health Authority Reporting and Submissions

Provides full electronic submission of Individual Case Safety Reports (ICSR) and periodic reports throughout the entire product lifecycle. Automatically generate submission ready reports including CIOMS I and MedWatch 3500A.

Active Monitoring and Notifications

Active monitoring with automated notification of issue detection for Adverse Events of Special Interest (AESI), Designated Medical Event (DME’s), Important Medical Events (IME’s), and Watchlists.

Interactive Dashboards and Reports

Drill down through real-time, interactive dashboards to narrow in on the exact source of processing and reporting delays, or see a specific ICSR. Take action directly from the reports to address hold-ups and stay on track for submission deadlines.

Configurable Case Management Workflows

Automate and track safety cases with standard and configurable workflows. Provides assignment, routing, email notifications, escalation, and tracking of tasks for groups or individuals.

Part of Veeva Vault Development Cloud

A single cloud platform for safety/pharmacovigilance, clinical, regulatory, and quality eliminates silos and drives end-to-end safety processes.

Resources for Vault Safety

Catalyst: Implement a Modern Drug Safety Solution in 12 Weeks
Video Catalyst: Implement a Modern Drug Safety Solution in 12 Weeks
Apellis: Owning Your Drug Safety Solution for Greater Control and Visibility
Webinar Apellis: Owning Your Drug Safety Solution for Greater Control and Visibility
Real-time Management and Management of Adverse Events
Product Brief Real-time Management and Management of Adverse Events
Why Safety Needs the Cloud
Blog Why Safety Needs the Cloud