Guidelines for Pharmacovigilance Signal Evaluation and Prioritization

1) Purpose

The purpose of this SOP is to define procedures for the systematic evaluation, prioritization, and management of pharmacovigilance signals to ensure timely identification and assessment of potential safety concerns.

2) Scope

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

3) Responsibilities

The Pharmacovigilance Signal Review Team is responsible for conducting signal evaluations. Medical reviewers provide clinical expertise and contribute to signal prioritization and risk assessment.

4) Procedure

4.1 Signal Detection and Identification

1. Utilize pharmacovigilance databases, literature sources, and regulatory databases to identify potential signals based on adverse event reports, epidemiological studies, and safety-related data.
2. Screen and prioritize signals for further evaluation based on predefined criteria, such as seriousness, unexpectedness, and potential public health impact.

4.2 Signal Assessment and Analysis

1. Conduct comprehensive assessment of identified signals, including review of case reports, clinical trial data, literature reviews, and previous safety assessments.
2. Evaluate clinical relevance, causal relationship, and potential mechanisms underlying identified signals.

4.3 Medical Review and Expert Consultation

1. Engage medical reviewers and therapeutic area experts to provide clinical assessment and expert opinion on signal characteristics, including severity, patient demographics, and clinical outcomes.
2. Collaborate with medical experts to prioritize signals for further investigation or risk management actions based on clinical significance and potential patient harm.

4.4 Signal Prioritization and Risk Assessment

1. Prioritize signals based on risk-benefit considerations, regulatory requirements, and potential impact on product safety profiles.
2. Perform quantitative and qualitative risk assessments to determine the need for additional data collection, regulatory reporting, or risk mitigation strategies.

4.5 Signal Management and Decision Making

1. Develop risk management plans or signal management strategies for signals requiring further investigation or regulatory action.
2. Document signal evaluation outcomes, decisions, and recommendations for risk communication, regulatory submissions, or product labeling updates.

4.6 Continuous Monitoring and Follow-up

1. Monitor evolving safety signals and update risk assessments based on new data, emerging trends, and regulatory feedback.
2. Implement proactive measures to address signal-related concerns, including additional studies, post-marketing commitments, or safety communication initiatives.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure

6) Documents, if any

Signal detection reports, signal assessment summaries, risk management plans, expert consultation logs.

7) Reference, if any

EMA Guideline on Good Pharmacovigilance Practices (GVP) Module IX – Signal Management, FDA Guidance for Industry – Best Practices in Drug and Biological Product Postmarketing Safety Surveillance.

8) SOP Version

Version 1.0