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, including investigation steps, regulatory reporting, and communication strategies.
2. Assign responsibilities for each action item to appropriate team members.
3. Monitor the implementation of action plans and update them as necessary.

4.5 Documentation and Reporting

1. Maintain detailed records of all signal detection, evaluation, prioritization, and action activities.
2. Prepare periodic reports on signal management activities for internal review and regulatory submission.
3. Ensure all documentation is stored securely and is easily accessible for audits and inspections.

4.6 Communication

1. Communicate significant signals and actions to relevant internal and external stakeholders, including regulatory authorities.
2. Conduct regular signal review meetings with the PV team and other relevant departments.
3. Provide training and updates on signal management procedures to all relevant staff.

5) Abbreviations, if any

PV – Pharmacovigilance

6) Documents, if any

Signal detection records, evaluation reports, prioritization logs, action plans, communication logs.

7) Reference, if any

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

8) SOP Version

Version 1.0