Guidelines for Managing Pharmacovigilance Signals

1) Purpose

The purpose of this SOP is to outline the procedures for managing pharmacovigilance signals, including their identification, evaluation, prioritization, and documentation, to ensure timely and appropriate action is taken.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in the signal management process, including those responsible for signal detection, evaluation, and communication.

3) Responsibilities

The Signal Management Team is responsible for handling all aspects of signal management. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and internal policies.

4) Procedure

4.1 Signal Detection

1. Collect data from various sources, including spontaneous reports, clinical studies, and literature.
2. Use statistical tools and manual review to detect potential signals.
3. Document detected signals in the signal management system.

4.2 Signal Evaluation

1. Assess the clinical significance and potential impact of detected signals.
2. Review relevant medical literature and additional data to support the evaluation.
3. Determine the need for further investigation or immediate action based on the evaluation.

4.3 Signal Prioritization

1. Prioritize signals based on their potential impact on patient safety and regulatory requirements.
2. Assign a risk level to each signal (e.g., high, medium, low) based on evaluation findings.
3. Develop a timeline for addressing each signal based on its priority level.

4.4 Signal Action Plan

1. Develop action plans for each prioritized signal,