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