Guidelines for Pharmacovigilance Metrics and KPIs

1) Purpose

The purpose of this SOP is to outline the procedures for defining, collecting, analyzing, and reporting pharmacovigilance metrics and key performance indicators (KPIs) to ensure the effectiveness and efficiency of pharmacovigilance activities.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in the collection, analysis, and reporting of metrics and KPIs.

3) Responsibilities

The Pharmacovigilance (PV) Metrics Coordinator is responsible for defining, collecting, and analyzing metrics and KPIs. The PV Manager oversees the process to ensure that metrics and KPIs are accurately reported and used to improve pharmacovigilance activities.

4) Procedure

4.1 Defining Metrics and KPIs

1. Identify key areas of pharmacovigilance activities that require monitoring, such as case processing times, reporting compliance, and signal detection efficiency.
2. Define specific, measurable, achievable, relevant, and time-bound (SMART) metrics and KPIs for each key area.
3. Document the defined metrics and KPIs in a metrics and KPIs register.

4.2 Data Collection

1. Establish data collection methods and tools for each defined metric and KPI.
2. Collect data on a regular basis (e.g., daily, weekly, monthly) as specified for each metric and KPI.
3. Ensure data is collected accurately and consistently across all relevant pharmacovigilance activities.

4.3 Data Analysis

1. Analyze the collected data to assess performance against defined metrics and KPIs.
2. Identify trends, patterns, and areas of concern that may require further investigation or action.
3. Document the results of the data analysis in a metrics and KPIs report.

4.4 Reporting

1. Prepare regular reports summarizing the performance against defined metrics and KPIs.
2. Distribute the reports to relevant stakeholders, including senior management, regulatory authorities, and pharmacovigilance personnel.
3. Ensure timely and transparent communication of the metrics and KPIs results.

4.5 Continuous Improvement

1. Review the metrics and KPIs regularly to ensure they remain relevant and aligned with regulatory requirements and organizational goals.
2. Identify areas for improvement based on the analysis of metrics and KPIs results.
3. Implement changes to pharmacovigilance processes and practices to improve performance against metrics and KPIs.

4.6 Documentation and Review

1. Maintain comprehensive records of all defined metrics and KPIs, data collection methods, data analysis results, and reports.
2. Conduct periodic reviews of the metrics and KPIs process to identify areas for improvement.
3. Update the metrics and KPIs SOP and related documents based on review findings and regulatory changes.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, KPI – Key Performance Indicator

6) Documents, if any

Metrics and KPIs register, data collection forms, data analysis reports, metrics and KPIs reports.

7) Reference, if any

ICH Guideline for Good Clinical Practice, FDA Guidance for Industry – Good Pharmacovigilance Practices, EU Guidelines on Good Pharmacovigilance Practices (GVP) Module IV – Pharmacovigilance Audits.

8) SOP Version

Version 1.0