Apart from Pharmacovigilance department, there are various allied departments that get reviewed during the inspection. The success of the Pharmacovigilance inspection is largely dependent on how the cross-functional stakeholders have fared. That would also mean that the Pharmacovigilance department needs to ensure that these stakeholders perform their work properly.

Pharmacovigilance Department (Primary)

Secondary:

• Medical Information
• Information Technology and Validation team
• BCP Team
• Regulatory Affairs
• Artwork and Labeling
• Website Management
• Product Quality
• Clinical
• Marketing / Sales
• Legal
• Market Research and allied
• Business Partners/ Vendors / Affiliates
• QPPV Office
• Administration and Front Desk

How about the people who report adverse events? Can we consider them as the stakeholders in Pharmacovigilance?