Vendor Oversight
Many pharmacovigilance activities are performed by external service providers. Effective vendor oversight helps ensure that outsourced activities remain compliant, controlled and inspection ready.
Why Vendor Oversight Matters
Marketing authorisation holders remain responsible for their pharmacovigilance obligations even when activities are outsourced to third-party organisations.
Regulators therefore expect appropriate oversight of vendors performing pharmacovigilance activities.
Role of the QPPV
The QPPV should maintain awareness of important outsourced pharmacovigilance activities and the arrangements used to oversee those activities.
Oversight includes understanding significant risks, performance indicators, compliance issues and escalation processes.
Commonly Outsourced Activities
- Case processing
- Literature screening
- Aggregate reporting
- Signal management support
- Medical information activities
- Safety database hosting
- Quality and compliance support
Key Elements of Oversight
- Defined responsibilities
- Quality agreements and contracts
- Performance monitoring
- Compliance metrics
- Issue escalation procedures
- Periodic review meetings
- Audit and inspection support
Vendor Performance Monitoring
Many organisations establish key performance indicators (KPIs) and compliance metrics to monitor vendor performance.
Performance trends should be reviewed regularly and significant issues should be escalated appropriately.
Inspection Expectations
Inspectors frequently review outsourced activities, vendor governance arrangements and evidence of ongoing oversight.
Organisations should be able to demonstrate how vendor performance is monitored and how compliance risks are identified and managed.
Relationship with the PSMF
Vendor arrangements are commonly described within the Pharmacovigilance System Master File (PSMF) and should accurately reflect how outsourced activities are managed.
Related Guides
Last reviewed: June 2026