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