Manage Application Roles

You must grant each user the appropriate application role for each organization that they must access by creating User Role Setup records.

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About User Role Setup

Vault Safety controls user access to information and records at the organization level. Each time you add new user or Organization to Vault Safety, you must assign application roles. Assign application roles by creating User Role Setup records.

Users must be assigned an application role in their organization to see Case-related data and participate in Case Processing workflows. A single user can have a different role in each organization they have access to. You can assign users to multiple organizations and multiple roles per organization.

Set Up User Roles

  1. On the Business Admin tab, go to User Role Setup and select Create Button.
    The Create User Role Setup page appears.
    You can also create user role setup records on a user profile from the Business Admin > Users page.
  2. Complete the following fields:
    • User: Select the user that you want to assign the role to.
    • Role: Select the Application Role that you want to assign the user.
    • Organization: Select the organization that the user should have access to with the application role.
    • Status: To make the role assignment active, select Active. To save the role assignment record for future use, select Inactive.
  3. Select Save.

Result

The user is granted access to case information and workflows for the organization, according to their application role.

Default Application Roles

The following application roles are standard in Vault Safety. Confirm with Veeva Services that the application roles in your environment meet your business requirements.

Note There are several other standard application roles available in your vault as part of the Vault Platform. We recommend that you use only the application roles listed below or custom application roles set up by Veeva Services. Other roles may not have access to Vault Safety application functionality.

Application Role Description

Data Entry

Assign the Data Entry role to users who are responsible for entering and revising case information.

Distribution Manager

Assign the Distribution Manager role to users who are responsible for sending safety information and reports, including ICSRs and aggregate reports, to partners and regulatory authorities.

ICSR Approver

Assign the ICSR Approver role to users who oversee all safety case processing, submissions, and compliance.
Users in this role can review and approve ICSRs and aggregate reports.

Note This role was previously named Head of Safety. It may appear as Head of Safety in your vault.

Intake

Assign the Intake role to users who are responsible for the initial intake and triage of adverse event reports.

Medical Coder

Assign the Medical Coder role to users who are responsible for coding medical events and products using MedDRA and WHODrug dictionaries.

Medical Reviewer

Assign the Medical Reviewer role to users who are responsible for reviewing Cases and determining the causality assessment for each adverse event.

Quality Controller (QC)

Assign the Quality Controller (QC) role to users who are responsible for reviewing case data entry and ensuring case processing quality control.

Safety Operations

Assign the Safety Operations role to users who oversee safety case processing operations.

Safety Writer

Assign the Safety Writer role to users who coordinate and author aggregate reports.


Manage Security Profiles
Configure User Access to Inbox Items
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