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?
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?