Guidelines for Pharmacovigilance Post-Marketing Surveillance

1) Purpose

The purpose of this SOP is to establish procedures for conducting post-marketing surveillance (PMS) to monitor the safety of pharmaceutical products after they have been authorized for use.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in post-marketing surveillance activities, including pharmacovigilance managers, safety scientists, and regulatory affairs personnel.

3) Responsibilities

The Post-Marketing Surveillance Team is responsible for monitoring and evaluating the safety profile of pharmaceutical products through ongoing surveillance activities. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and effective post-marketing surveillance.

4) Procedure

4.1 Signal Detection and Data Collection

1. Monitor incoming safety data from spontaneous reports, clinical studies, literature, and other sources.
2. Identify potential safety signals based on predefined criteria and statistical analyses.
3. Collect and compile relevant safety data for further evaluation.

4.2 Signal Assessment and Prioritization

1. Analyze and assess safety signals to determine their clinical relevance and potential impact on patient safety.
2. Prioritize signals based on severity, frequency, and potential risk-benefit considerations.
3. Document assessment findings and recommendations for further action.

4.3 Risk Evaluation and Decision Making

1. Evaluate identified safety signals in the context of existing safety data and regulatory requirements.
2. Make decisions regarding risk minimization measures, including label updates, communication strategies, and regulatory submissions.
3. Consult with cross-functional teams and regulatory authorities as necessary.

4.4 Periodic Safety Update Reports (PSURs)

1. Prepare and submit PSURs to regulatory authorities as per regulatory requirements and timelines.
2. Ensure PSURs are comprehensive, accurate, and reflective of the current safety profile of the product.
3. Include findings from post-marketing surveillance activities and safety signal assessments in PSURs.

4.5 Pharmacovigilance System Master File (PSMF)

1. Maintain the Pharmacovigilance System Master File (PSMF) to document PMS activities and compliance with pharmacovigilance regulations.
2. Update the PSMF with new safety data, risk management activities, and changes in pharmacovigilance practices.
3. Ensure the PSMF is readily accessible for inspections and audits.

4.6 Communication and Stakeholder Engagement

1. Communicate safety findings and updates to internal stakeholders, including senior management and product teams.
2. Engage external stakeholders, including healthcare professionals and patients, through appropriate communication channels.
3. Facilitate transparency and trust in pharmacovigilance activities and safety assessments.

5) Abbreviations, if any

PV – Pharmacovigilance, PMS – Post-Marketing Surveillance, PSUR – Periodic Safety Update Report, PSMF – Pharmacovigilance System Master File

6) Documents, if any

Signal detection reports, signal assessment summaries, PSURs, PSMF.

7) Reference, if any

ICH E2E Pharmacovigilance Planning, EU Good Pharmacovigilance Practices (GVP) Module IX – Signal Management.

8) SOP Version

Version 1.0