Guidelines for Pharmacovigilance Safety Signal Investigation

1) Purpose

The purpose of this SOP is to outline procedures for the investigation and evaluation of safety signals identified during pharmacovigilance activities.

2) Scope

This SOP applies to personnel involved in pharmacovigilance signal detection, including pharmacovigilance officers, safety scientists, medical reviewers, and risk management specialists.

3) Responsibilities

The Pharmacovigilance Safety Scientist is responsible for initiating and conducting safety signal investigations. Pharmacovigilance officers and medical reviewers contribute to signal evaluation and decision-making.

4) Procedure

4.1 Signal Detection and Prioritization

1. Receive and review potential safety signals identified through spontaneous reports, literature review, clinical trials, and post-marketing surveillance.
2. Prioritize signals based on seriousness, potential impact on patient safety, and regulatory reporting requirements.

4.2 Signal Investigation Planning

1. Formulate an investigation plan outlining objectives, methodologies, and timelines for signal evaluation.
2. Assign roles and responsibilities for signal investigation team members, including data collection, analysis, and decision-making.

4.3 Data Collection and Analysis

1. Gather relevant data sources, including adverse event reports, clinical trial data, epidemiological studies, and published literature.
2. Analyze quantitative and qualitative data to assess the strength of association between the drug or medical product and the identified safety signal.

4.4 Signal Evaluation and Assessment

1. Evaluate the clinical relevance and potential causality of the safety signal based on available evidence and medical judgment.
2. Conduct thorough risk-benefit assessments to determine the need for further action, including regulatory reporting, risk minimization measures, or product labeling updates.

4.5 Decision-Making and Action Planning

1. Document findings and recommendations from the safety signal investigation team.
2. Develop risk management strategies and action plans to address identified safety concerns, collaborating with regulatory affairs and product teams as necessary.

4.6 Communication and Reporting

1. Communicate investigation outcomes and recommendations to internal stakeholders, including pharmacovigilance management, regulatory authorities, and external partners.
2. Prepare and submit regulatory reports (e.g., Periodic Safety Update Reports, Risk Management Plans) as required by regulatory guidelines.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure

6) Documents, if any

Signal investigation plan, signal evaluation reports, risk management strategy documents, regulatory submission templates.

7) Reference, if any

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.

8) SOP Version

Version 1.0