• Manoj Swaminathan

Pharmacovigilance Vendors and Audit Readiness

Common questions asked by the Pharmacovigilance Inspector, with regards to Pharmacovigilance vendors

  • Are all the Pharmacovigilance activities handled in-house?

  • Have you outsourced any of your Pharmacovigilance activities?

  • On what basis was the vendor selected? Qualification process? Audit?

  • Onboarding process?

  • Does the vendor have any BCP measures in place?

  • Can you show the details of this vendor, in Annex B of PSMF?

  • Do you have a contract with with vendor?

  • Could you please share it? Is there a GDPR clause?

  • Is the vendor trained on your company's data integrity guidelines?

  • Have you ever audited the vendor?

  • Were there any observations?

  • Are all the corrective/ preventive actions closed?

  • Does the main body of your PSMF have any of the open corrective/ preventive actions associated with these observations?

  • Does your Annex I (logbook) have any response?

  • When are you next auditing your vendor?

  • Can you show the audit schedule in Annex G of your PSMF?

  • Is the vendor trained on your company's SOPs? Is there a system for ensuring training on updated or new SOPs/WIs? Do the vendor's employees maintain training files?

  • How is the data shared between your company and the vendor? Does the vendor have access to the client's mailbox?