QPPV Metrics
Metrics help QPPVs maintain visibility over the performance, compliance and effectiveness of the pharmacovigilance system.
Why Metrics Matter
Large pharmacovigilance systems generate significant volumes of operational information. Metrics transform this information into meaningful management insights that support oversight and decision-making.
Case Processing Metrics
- Submission timeliness
- Case volumes
- Backlog levels
- Follow-up rates
- Processing cycle times
Compliance Metrics
- Reporting compliance
- Training compliance
- CAPA completion rates
- Literature screening compliance
- Audit observations
Vendor Oversight Metrics
- SLA performance
- Quality indicators
- Audit findings
- Compliance trends
- Escalation frequency
Governance Metrics
- Open compliance risks
- Escalations
- Committee actions
- Inspection findings
- CAPA effectiveness
Role of the QPPV
The QPPV should understand significant trends, emerging risks and compliance issues identified through pharmacovigilance metrics.
Metrics support oversight but do not replace professional judgement.
Inspection Perspective
Inspectors frequently review management information and metrics to assess whether organisations actively monitor pharmacovigilance performance and compliance.
Last reviewed: June 2026