Guidelines for Pharmacovigilance Adverse Event (AE) Reporting

1) Purpose

The purpose of this SOP is to outline procedures for the reporting of adverse events (AEs) associated with pharmaceutical products.

2) Scope

This SOP applies to all pharmacovigilance personnel responsible for AE reporting, including pharmacovigilance managers, safety scientists, and clinical research associates.

3) Responsibilities

The AE Reporting Team is responsible for timely identification, assessment, documentation, and reporting of AEs in compliance with regulatory requirements. The Pharmacovigilance (PV) Manager oversees AE reporting activities to ensure patient safety and regulatory compliance.

4) Procedure

4.1 AE Identification and Documentation

1. Receive and document AE reports from clinical trials, spontaneous reports, literature, and other sources.
2. Classify AEs based on severity, seriousness criteria, and regulatory reporting requirements.
3. Enter AE data into the pharmacovigilance database for further assessment.

4.2 AE Assessment and Causality Analysis

1. Assess AEs to determine the causal relationship between the pharmaceutical product and the reported event.
2. Conduct medical review and analysis of available data, including patient medical history and concomitant medications.
3. Document causality assessment findings and decisions.

4.3 Reporting and Communication

1. Prepare and submit individual case safety reports (ICSRs) to regulatory authorities as per reporting timelines and requirements.
2. Communicate AE findings and updates to relevant stakeholders, including clinical investigators and regulatory agencies.
3. Ensure accurate and timely reporting of AEs to support patient safety and regulatory compliance.

4.4 Follow-up and Documentation

1. Monitor follow-up activities related to reported AEs, including additional information requests and patient outcome assessments.
2. Update AE records with new information and outcomes as they become available.
3. Document all follow-up activities and communications for audit and inspection purposes.

4.5 Quality Control and Continuous Improvement

1. Implement quality control checks to ensure accuracy and completeness of AE data and reporting.
2. Review AE reporting processes and identify opportunities for process improvement.
3. Participate in training and development activities to enhance AE reporting competencies.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, AE – Adverse Event, ICSR – Individual Case Safety Report

6) Documents, if any

AE reports, individual case safety reports (ICSRs), follow-up documentation.

7) Reference, if any

ICH E2E Pharmacovigilance Planning, EU Good Pharmacovigilance Practices (GVP) Module VI – Management and Reporting of Adverse Reactions to Medicinal Products.

8) SOP Version

Version 1.0