EudraVigilance Metrics and KPIs for QPPVs

Introduction

A pharmacovigilance system cannot be effectively managed without meaningful metrics.

Although most organisations maintain some form of compliance reporting, many dashboards focus on operational workload rather than regulatory risk.

For QPPVs, the objective is not merely to understand what work was completed.

The objective is to understand whether the pharmacovigilance system remains compliant, controlled and capable of protecting patient safety.

EudraVigilance metrics provide visibility into the health of critical pharmacovigilance processes and can help identify emerging risks before they become inspection findings.

Why Metrics Matter

Metrics support:

• Compliance monitoring
• Trend analysis
• Resource planning
• Risk identification
• Vendor oversight
• Inspection readiness
• Management review

Without objective performance indicators, organisations may not recognise deteriorating compliance until a significant issue occurs.

Characteristics of a Good KPI

A useful pharmacovigilance KPI should be:

• Relevant
• Objective
• Actionable
• Repeatable
• Risk-focused

Metrics that cannot influence decision-making often add little value.

The best KPIs highlight emerging compliance risks early enough for intervention.

Reporting Compliance Metrics

Reporting compliance remains one of the most important EudraVigilance performance areas.

On-Time Reporting Rate

Measures the percentage of reports submitted within required timelines.

Example:

This metric is frequently reviewed by inspectors.

Late Reporting Rate

Tracks reports submitted after applicable deadlines.

A rising trend may indicate:

• Resource shortages
• Process bottlenecks
• Training issues
• System failures

Significant Reporting Delays

Some organisations monitor:

• Cases >7 days late
• Cases >15 days late
• Cases >30 days late

These indicators often reveal systemic weaknesses more effectively than average compliance percentages.

Acknowledgement Metrics

Submission alone does not demonstrate compliance.

Organisations should monitor acknowledgement outcomes.

Rejection Rate

Measures the percentage of reports rejected by EudraVigilance.

A high rejection rate may indicate:

• Coding issues
• Data quality problems
• Technical failures
• Validation weaknesses

Unresolved Rejections

Tracks rejected reports that remain open beyond defined timelines.

This metric can highlight compliance exposure.

Acknowledgement Review Completion

Measures whether acknowledgements are reviewed within established procedures.

Failure to review acknowledgements is a recurring inspection concern.

Reconciliation Metrics

Reconciliation activities help ensure that reporting data remain complete and accurate.

Reconciliation Completion Rate

Measures completion of planned reconciliation activities.

Outstanding Discrepancies

Tracks unresolved differences identified during reconciliation.

Examples may include:

• Missing reports
• Duplicate reports
• Acceptance mismatches

Time to Resolution

Measures how quickly discrepancies are investigated and resolved.

Signal Management Metrics

Signal management metrics help demonstrate ongoing safety surveillance.

EVDAS Review Completion

Measures completion of scheduled EVDAS reviews.

For additional information see:

[[evdas-and-signal-detection]]

Signal Validation Timeliness

Tracks how quickly potential signals progress through validation activities.

Open Signal Inventory

Measures the number of signals currently under evaluation.

Trend monitoring may help identify resource constraints.

Signal Escalation Timeliness

Assesses whether significant safety concerns are escalated within expected timelines.

Medical Literature Monitoring Metrics

Literature surveillance processes may also be monitored.

Examples include:

• Literature review completion
• Case identification rates
• Literature case processing times
• MLM case review completion

For additional information see:

[[medical-literature-monitoring]]

Access Governance Metrics

Access governance is often overlooked until inspections occur.

Useful indicators include:

Access Review Completion

Measures completion of scheduled access reviews.

Dormant Accounts

Tracks inactive users retaining access.

Training Compliance

Measures whether authorised users maintain required training status.

Segregation of Duties Exceptions

Identifies users holding potentially conflicting responsibilities.

Vendor Oversight Metrics

Outsourced activities should be monitored through defined KPIs.

Examples include:

• Reporting compliance
• Case processing timeliness
• Quality review outcomes
• Deviation rates
• CAPA completion

For additional information see:

[[vendor-oversight]]

CAPA Metrics

CAPA effectiveness is often a key inspection focus.

Useful measures include:

Open CAPAs

Number of active CAPAs.

Overdue CAPAs

CAPAs exceeding planned completion dates.

Repeat Findings

Repeated observations may indicate ineffective CAPAs.

CAPA Effectiveness Rate

Measures whether implemented actions successfully resolved the underlying issue.

QPPV Dashboard Design

A QPPV dashboard should focus on risk rather than volume.

A practical dashboard often includes:

• Reporting compliance
• Rejection rates
• Reconciliation status
• Open signals
• Significant deviations
• Vendor performance
• CAPA status

The objective is to provide rapid visibility of compliance risks.

Trending and Thresholds

Individual metrics are useful.

Trends are often more useful.

Organisations should establish:

• Alert thresholds
• Escalation thresholds
• Review frequencies
• Management reporting expectations

Trend analysis helps identify gradual deterioration before compliance is affected.

Inspection Perspective

Inspectors frequently review metrics to understand how organisations monitor their pharmacovigilance systems.

Inspectors may assess:

• KPI definitions
• Governance review processes
• Escalation practices
• Trend analysis
• Management actions

Metrics are often viewed as evidence of system oversight.

Common Metric Weaknesses

Observed weaknesses include:

• Excessive focus on workload
• Lack of risk indicators
• Missing trend analysis
• Poor escalation criteria
• Inconsistent reporting

A large dashboard does not necessarily indicate effective oversight.

Relevant metrics matter more than quantity.

Practical KPI Framework for QPPVs

A simple EudraVigilance KPI framework may include:

This provides visibility across both operational and governance activities.

Key Takeaways

• Metrics help demonstrate pharmacovigilance system control.
• Reporting compliance remains a critical performance area.
• Acknowledgement and reconciliation metrics should not be overlooked.
• Signal management activities should be monitored through defined KPIs.
• Access governance and vendor oversight require objective measurement.
• QPPV dashboards should focus on compliance risk rather than activity volume.
• Inspectors frequently review metrics when assessing system effectiveness.

References

1. EMA Good Pharmacovigilance Practices (GVP) Module I – Pharmacovigilance Systems and Their Quality Systems.
2. EMA Good Pharmacovigilance Practices (GVP) Module III – Pharmacovigilance Inspections.
3. EMA Good Pharmacovigilance Practices (GVP) Module VI – Collection, Management and Submission of Reports of Suspected Adverse Reactions.
4. EMA Good Pharmacovigilance Practices (GVP) Module IX – Signal Management.
5. Regulation (EC) No 726/2004.
6. Directive 2001/83/EC.
7. Commission Implementing Regulation (EU) No 520/2012.