• Manoj Swaminathan

Stakeholders in Pharmacovigilance / Scope of Pharmacovigilance Audit or Inspection

Updated: Aug 11

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

Pharmacovigilance Department (Primary)


  • 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