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 the 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?