Introduction

Under the EU Good Pharmacovigilance Practices (GVP), Marketing Authorization Holders (MAHs) are required to maintain a fully functioning, compliant, and continuously monitored Pharmacovigilance (PV) system. To achieve this, PV departments must track clear and measurable Key Performance Indicators (KPIs) that reflect system performance, regulatory compliance, operational efficiency, and oversight quality.

1. ICSR Submission Timeliness

GVP Module VI – Expedited Reporting Obligations

ICSR expedited reporting is one of the most heavily scrutinized areas in PV inspections. Regulatory authorities expect MAHs to meet strict 7-day and 15-day reporting timelines.

What to Measure

• Delays in safety document submission can:
• Impact regulatory decision-making
• Delay benefit–risk evaluations
• Result in inspection findings for non-compliance
• Signal insufficient internal planning or oversight
• Timeliness is a direct indicator of PV system control and QPPV oversight, making it a critical KPI under GVP expectations.

2.Case Processing Turnaround Time

Internal Timeliness to Prevent Overall Delays

Even if submission is on time, the internal process must be efficient (case intake, data entry, assessment, QC).

What to Track

• Time from case receipt → data entry
• Time from medical review → finalization
• Time to QC and sign-off

3. Case Quality & Error Rate

GVP Module I & IV – Quality Management System (QMS) Expectations

Case quality determines the reliability of the product’s safety profile. Inspectors closely examine error trends.

What to Measure

• QC findings per case
• Rate of critical vs. major errors
• Recurrence of similar issues

GVP Requirement

Errors and deviations must be addressed through CAPAs, documented within the PV QMS.

4. Literature Screening Compliance

GVP Module VI – Mandatory Weekly Literature Monitoring

MAHs must ensure weekly global and local literature searches for safety information.

What to Measure

• % of weekly searches completed
• Documentation and audit evidence
• Timely extraction and reporting of cases

Why It Matters

Missed weekly searches are considered non-compliance during inspections.

5. Signal Management Timeliness

GVP Module IX – Signal Detection & Evaluation

A robust signal management system ensures early detection of safety concerns.

What to Track

• Timeliness of signal detection and validation
• Time from validation → assessment
• Documentation completeness

Regulatory Expectation

Signal activities must follow a predefined, documented timeline and be auditable.

6. Safety Document Timeliness (PSURs, DSURs, RMPs)

• GVP Module VII – Periodic Safety Update Reports (PSURs)
• GVP Module VI / Clinical Trial Directive & Regulation – Development Safety Update Reports (DSURs)
• GVP Module V – Risk Management Systems RMPs- Periodic safety documents reflect the MAH’s understanding of the evolving risk–benefit profile.

What to Measure

• On-time submission of PSURs/PBRERs in line with EURD list or specific regulatory requests
• Timeliness of DSUR preparation, review, and submission for clinical trial products
• RMP update timelines, including revisions triggered by:
• Newly identified risks
• Changes in safety profile
• Outcomes from signal detection
• Regulatory authority requests

Why It Matters

Delays in safety document submission can:

• Impact regulatory decision-making
• Delay benefit–risk evaluations
• Result in inspection findings for non-compliance
• Signal insufficient internal planning or oversight

Timeliness is a direct indicator of PV system control and QPPV oversight, making it a critical KPI under GVP expectations.

7. QPPV Oversight & PSMF Compliance

GVP Module II – System Master File Governance

The QPPV must maintain full oversight of the PV system, supported by measurable KPIs.

KPIs Include

• Frequency and timeliness of PSMF updates
• Review of deviations, KPIs, and system performance
• Oversight of affiliates and vendors
• Timely escalation and documentation of issues

GVP Requirement

The QPPV must have “sufficient authority and oversight” over the entire PV system.

8. PV Training Compliance

GVP Modules I & II – Competency Requirements

Training compliance ensures all personnel involved in PV activities understand their roles and obligations.

What to Measure

• % of staff completing PV training on time
• SOP and role-specific training completion
• Documentation proof for audits

Why It Matters

Training gaps are a frequent inspection finding and undermine system credibility.

9. Vendor & Partner Oversight

GVP Module IV – Oversight of Outsourced Activities

If PV activities are outsourced (case processing, literature screening, medical information), MAHs must proactively supervise vendors.

What to Track

• Vendor timeliness KPIs
• Vendor quality scores
• Number of deviations, escalations, or CAPAs
• Adherence to the PV Agreement (SDEA)

GVP Requirement

The MAH retains full responsibility even when activities are outsourced.

10. CAPA & Deviation Closure Timeliness

GVP Module I – QMS, CAPAs, and Continuous Improvement

Effective CAPA management is a key indicator of a mature PV system.

What to Measure

• % of CAPAs closed on or before the due date
• Number of deviations and recurrence rates
• Effectiveness checks

Why It Matters

Regulators expect MAHs to identify root causes and prevent re-occurrence—not just document issues.

Key Takeaways

• KPIs provide measurable evidence of compliance and performance under GVP.
• Timeliness (ICSRs, literature, safety documents) remains the strongest focus in inspections.
• Quality metrics (error rates, QC findings, CAPAs) reflect system robustness.
• Training and vendor management are core GVP requirements.
• The QPPV must maintain oversight supported by strong governance KPIs.
• A well-structured KPI framework strengthens inspection readiness and patient safety.