SOP for Pharmacovigilance Safety Signal Investigation

Purpose

This SOP aims to define the procedures for investigating and assessing safety signals that emerge during pharmacovigilance processes.

Scope

The SOP applies to all personnel engaged in signal detection for pharmacovigilance, such as pharmacovigilance officers, safety scientists, medical reviewers, and risk management specialists.

Responsibilities

The Pharmacovigilance Safety Scientist is responsible for initiating and conducting investigations into safety signals.

Pharmacovigilance officers and medical reviewers are involved in signal evaluation and decision-making processes.

Procedure

1. Signal Detection and Prioritization

• Review potential safety signals derived from sources like spontaneous reports, literature reviews, clinical trials, and post-marketing surveillance.
• Assign priority to signals based on their severity, potential impact on patient safety, and regulatory reporting obligations.

2. Signal Investigation Planning

• Develop an investigation plan detailing objectives, methodologies, and timelines for signal evaluation.
• Allocate roles and responsibilities to investigation team members for tasks such as data collection, analysis, and decision-making.

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3. Data Collection and Analysis

• Collect relevant data from sources like adverse event reports, clinical trials, epidemiological studies, and published literature.
• Perform quantitative and qualitative data analyses to evaluate the association strength between the medical product and the identified safety signal.

4. Signal Evaluation and Assessment

• Assess the clinical significance and possible causality of the safety signal using available evidence and expert medical judgment.
• Conduct a comprehensive risk-benefit assessment to decide on further actions, such as regulatory reporting, risk minimization strategies, or updates to product labeling.

5. Decision-Making and Action Planning

• Document the findings and recommendations made by the safety signal investigation team.
• Develop action plans and risk management strategies in collaboration with regulatory affairs and product teams to address safety concerns.

6. Communication and Reporting

• Share investigation results and recommendations with internal stakeholders, regulatory bodies, and external partners.
• Prepare and file regulatory documents, such as Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs), in accordance with guidelines.

Abbreviations

PV: Pharmacovigilance

SOP: Standard Operating Procedure

Documents

Signal investigation plans

Signal evaluation reports

Risk management strategy documentation

Templates for regulatory submissions

References

ICH E2E: Pharmacovigilance Planning

ICH E2D: Post-Approval Safety Data Management

ICH E2C: Pharmacovigilance Signal Detection

MedDRA MSSO: Medical Dictionary for Regulatory Activities Maintenance and Support Services Organization

Revision History

Nil

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