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Pharmacovigilance Regulatory Expectations

What Do Inspectors Check for Pharmacovigilance KPI Monitoring and Dashboards?

Pharmacovigilance systems must monitor performance using KPI dashboards and reporting tools. Regulators expect organisations to demonstrate real-time or periodic monitoring of safety metrics, trend analysis, and clear visibility of compliance risks through structured dashboards and reports.

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The short version

What teams need to understand

  • Pharmacovigilance systems should monitor performance through structured KPI dashboards and reporting tools.
  • Dashboards should provide visibility of key safety metrics, trends, and compliance risks.
  • Performance indicators should be monitored against defined targets and thresholds.
  • Trend analysis should be used to identify emerging compliance or operational issues.
  • KPI dashboards should support governance review and decision-making processes.
  • Inspection-ready evidence should demonstrate that KPI monitoring is ongoing, structured, and actionable.

Regulatory expectation

What regulators expect

Each expectation should be supported by controlled documentation, traceable records, clear ownership, and evidence that the process works in practice.

  • PV systems must actively monitor performance using defined metrics.
  • KPI dashboards must provide visibility of compliance and operational performance.
  • Performance must be assessed against defined targets and thresholds.
  • Trend analysis must be used to identify emerging issues.
  • KPI monitoring must support governance and decision-making.

Why it matters

What this means in practice

Inspectors assess whether pharmacovigilance systems actively monitor performance through KPI dashboards and reporting tools. They typically review dashboard outputs, trend analysis, and evidence that performance metrics are monitored, interpreted, and used to support oversight and decision-making.

Questions this page answers

What dashboards do inspectors expect in pharmacovigilance?
How should PV KPIs be monitored?
What is a pharmacovigilance KPI dashboard?
What evidence shows PV performance monitoring?
How do inspectors review KPI dashboards?
What should a PV KPI dashboard include?
How are pharmacovigilance metrics monitored in practice?
What tools are used to monitor PV performance?
How do inspectors verify KPI trends and performance?
What does a pharmacovigilance dashboard look like?

Inspection evidence

Evidence teams should be able to show

PV KPI Dashboard

  • Monthly KPI dashboard reports
  • RAG (Red-Amber-Green) status indicators
  • Trend charts showing KPI performance over time
  • Dashboard outputs presented in governance meetings
  • Automated or system-generated KPI reports

KPI Data Sources and Systems

  • Safety database outputs (e.g. Argus reports)
  • Manual or automated KPI tracking systems
  • Data extraction logic for KPI calculation
  • Documentation showing how KPI data is generated

Trend Analysis Evidence

  • Monthly or quarterly KPI trend reports
  • Identification of performance deterioration or improvement
  • Comparative performance across time periods
  • Visual charts demonstrating KPI trends

KPI Threshold and Status Indicators

  • Defined thresholds for KPI performance (Green, Amber, Red)
  • Evidence of KPI status classification
  • Documentation explaining threshold logic
  • Trigger points for escalation

Regulatory Basis (Primary Sources)

  • GVP Module I - pharmacovigilance systems must monitor performance and quality
  • GVP Module IV - expectations for monitoring and oversight of PV systems
  • ICH E2D - monitoring of case processing and reporting performance
  • ICH E2E - pharmacovigilance planning and performance monitoring
  • MHRA GPvP guidance - expectations for PV system monitoring and oversight
  • FDA pharmacovigilance guidance - monitoring compliance and safety performance

Typical Inspection Questions (What Inspectors Ask)

  • Show me your pharmacovigilance KPI dashboard.
  • How do you monitor PV performance?
  • What trends have you identified in your KPIs?
  • How do you determine KPI status (Green, Amber, Red)?
  • What actions are taken when KPI performance deteriorates?

Common failure patterns

KPI dashboards are not maintained or not available during inspection.
Metrics are collected but not visualised or interpreted.
No trend analysis is performed on KPI data.
KPI status indicators are not defined or inconsistently applied.
Dashboards exist but are not used for governance decision-making.

What good looks like

  • Structured KPI dashboards showing current performance and trends.
  • Clear RAG status indicators aligned with defined thresholds.
  • Regular trend analysis identifying performance risks and improvements.
  • Dashboards used actively in governance meetings.
  • KPI monitoring integrated into decision-making processes.

How teams operationalise it

  • Develop KPI dashboards displaying key pharmacovigilance metrics.
  • Define thresholds and implement RAG status indicators.
  • Ensure dashboards are updated regularly using reliable data sources.
  • Perform trend analysis on KPI data over time.
  • Use dashboard outputs to support governance and decision-making.

From expectation to working control

Find the documentation that supports this work

Review the related toolkit to understand its purpose, included files, and how it supports this regulatory expectation.

Browse pharmacovigilance toolkitsView related toolkit

Frequently asked questions

What is a pharmacovigilance KPI dashboard?

A KPI dashboard is a visual tool used to monitor pharmacovigilance performance metrics, typically showing compliance, timeliness, and quality indicators in a structured format.

What should a PV KPI dashboard include?

Dashboards typically include KPI values, targets, RAG status indicators, and trend charts showing performance over time.

Do inspectors request KPI dashboards?

Yes. Inspectors frequently request dashboard outputs to verify that pharmacovigilance systems monitor performance effectively.

How are KPI trends used in pharmacovigilance?

Trend analysis helps identify performance deterioration or improvement and supports proactive risk management.

How do inspectors verify KPI monitoring?

Inspectors typically review dashboards, trend reports, and governance meeting records to confirm that KPI monitoring is active and meaningful.

What are examples of metrics shown in PV dashboards?

Examples include ICSR reporting timeliness, case quality scores, signal evaluation timelines, PSUR submission compliance, and CAPA closure rates.

Source boundary

Regulatory sources

These primary sources inform this structured interpretation. Always confirm current requirements against the original source and the requirements applicable to your organisation, product, and jurisdiction.

European Medicines Agency (EMA)

  • Good pharmacovigilance practices (GVP)

    View source

  • Guideline on good pharmacovigilance practices (GVP) - Module I

    View source

International Council for Harmonisation (ICH)

  • Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting (E2D)

    View source

  • Pharmacovigilance Planning (E2E)

    View source

U.S. Food and Drug Administration (FDA)

  • Postmarketing Safety Reporting for Human Drug and Biological Products

    View source

UK MHRA (GOV.UK)