Enable Generate Draft Pharmacovigilance Agreement Documents

With the 25R3 release, Veeva SafetyDocs introduces the ability to configure templates for pharmacovigilance agreement (PVA) document generation. This feature allows you to create PVA Outlines that users can use to generate draft pharmacovigilance agreement (PVA) documents for a PV Agreement with less manual effort.

After you have enabled this feature, see the following articles for more information:

• Configure PVA Outlines
• Manage Pharmacovigilance Agreements

Prerequisites

Before enabling this feature in your Vault, you must enable PVA Management.

Overview

Complete the following procedures to enable this feature in your Vault:

• Update object layouts
• Grant PVA Actions object permissions
• Configure PV Agreement actions
• Add a PVA Outlines tab to the PVAs tab collection
• Create PVA-specific Word Formatted Output Templates

Update Object Layouts

To update object layouts:

1. Copy the standard layout for the following objects and ensure the new layout is active:
   • PVA Outline
   • PVA Outline Clause
   • PVA Outline Subclause
   • PV Agreement
2. Set the copied layout as the default.
3. Delete any other existing custom layouts.

Additionally, you must update the PVA Outline layout to:

1. Add the Word Formatted Output Template control field with the Slider () icon to the Details section above the existing Word Formatted Output Template field.
2. Remove the original Word Formatted Output Template field.

Grant PVA Actions Object Permissions

Ensure your permission sets are updated to grant the appropriate level of access for users to objects and fields according to your organization’s process. Manage object permissions from Admin > Users & Groups > Permission Sets > [Permission Set] > Objects > [Object].

Update the custom PVA Actions permission set to add Read, Create, Edit, and Delete permissions for the following objects:

• PVA Outline, including View permission for the Word Formatted Output Template object control permission
• PVA Outline Clause
• PVA Outline Subclause

Configure PV Agreement Actions

To configure PV Agreement actions:

1. Assign the Generate Draft PV Agreement action to the PV Agreement object.
2. Add the action as a user action on the Initiated lifecycle state using the following criteria:
   • Condition Type: Select Always
   • Allow the following actions
     • Select Generate Draft PV Agreement
     • Action Label: Enter Generate Draft PVA

Create a PVA Outlines Tab

Create a custom object sub-tab under the PVAs tab collection for the PVA Outlines object.