Vault Safety Overview

Veeva Vault Safety is a modern application for the collection, management, and real-time oversight of adverse events.

Note Beginning with 24R1 in April 2024 and for all subsequent releases, the new Vault Safety Help site is the official site for all Vault Safety Help content. This site reflects updates until the 23R3 release only. For the latest information, visit the new site.

About Vault Safety

Vault Safety is a Vault Vault is a cloud-based Content Management System (CMS) developed by Veeva Systems. application with the ability to manage adverse event information and documentation in a single system. Vault Safety enables sponsors to make faster, more informed decisions and improve compliance throughout the product lifecycle.

Case Intake

The Case intake objects, such as Inbox Items and AERs AER stands for adverse event report. AER is a type of the Case object in Vault Safety that captures basic case information. AERs precede Case creation and are used for early triage. You can create a Case in Vault Safety by promoting an AER, provided that the AER contains key information. , capture the basic report details and can be promoted to a new or follow-up Case. You can view all Inbox Items on the Inbox tab.

Note AERs are in a sunset period, meaning they are being phased out. Using the new Inbox (Inbox Item) is currently optional but highly recommended due to the functional and usability benefits over the AER Inbox. All customers must use Inbox Items for intake by 23R3 (December 2023), when AER creation will be disabled. For more information, see Inbox Item Transition From AERs.

Learn more about Inbox Items in Case Intake.

Case Processing

Case processing features help to streamline adverse event management with role-based assignment and routing of cases for follow-up and medical review, parallel case processing, and intelligent duplicate detection and follow-up.

Configurable Case Management Workflows

You can automate and track cases with standard and configurable workflows. Configurable case management workflows provide assignment, routing, email notifications, escalation, and tracking of tasks for groups or individuals.

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, Vault Safety aligns with GxP practices globally.

Standardized Medical Dictionaries

Vault Safety supports the industry-standard World Health Organization Drug Dictionaries (WHODrug C3), the Medical Dictionary for Regulatory Affairs (MedDRA), and the Unified Code for Units of Measure (UCUM).

Health Authority Reporting and Submissions

Vault Safety provides full electronic submission of Individual Case Safety Reports (ICSR) and periodic reports throughout the entire product lifecycle.

Interactive Dashboards and Reports

To narrow in on the exact source of processing and reporting delays, drill down through real-time, interactive dashboards. You can take action directly from the reports to address hold-ups and stay on track for submission deadlines.

First Steps for Safety Administrators