Guidelines for Pharmacovigilance Serious Adverse Event (SAE) Management
1) Purpose
The purpose of this SOP is to outline procedures for the management and reporting of serious adverse events (SAEs) related to pharmaceutical products.
2) Scope
This SOP applies to all pharmacovigilance personnel responsible for SAE management, including pharmacovigilance managers, safety scientists, and clinical research associates.
3) Responsibilities
The SAE Management Team is responsible for timely identification, assessment, documentation, and reporting of SAEs in compliance with regulatory requirements. The Pharmacovigilance (PV) Manager oversees SAE management activities to ensure patient safety and regulatory compliance.
4) Procedure
4.1 SAE Identification and Documentation
- Receive and document SAE reports from clinical trials, spontaneous reports, literature, and other sources.
- Classify SAEs based on severity, seriousness criteria, and regulatory reporting requirements.
- Enter SAE data into the pharmacovigilance database for further assessment.
4.2 SAE Assessment and Causality Analysis
- Assess SAEs to determine the causal relationship between the pharmaceutical product and the reported event.
- Conduct medical review and analysis of available data, including patient medical history and concomitant medications.
- Document causality assessment findings and decisions.
4.3 Reporting and Communication
- Prepare and submit expedited and periodic safety reports (PSURs) to regulatory authorities as per reporting timelines and requirements.
- Communicate SAE findings and updates to relevant stakeholders, including clinical investigators and regulatory agencies.
- Ensure accurate and timely reporting of SAEs to support patient safety and regulatory compliance.
4.4 Follow-up and Documentation
- Monitor follow-up activities related to reported SAEs, including additional information requests and patient outcome assessments.
- Update SAE records with new information and outcomes as they become available.
- Document all follow-up activities and communications for audit and inspection purposes.
4.5 Quality Control and Continuous Improvement
- Implement quality control checks to ensure accuracy and completeness of SAE data and reporting.
- Review SAE management processes and identify opportunities for process improvement.
- Participate in training and development activities to enhance SAE management competencies.
5) Abbreviations, if any
PV – Pharmacovigilance, SOP – Standard Operating Procedure, SAE – Serious Adverse Event, PSUR – Periodic Safety Update Report
6) Documents, if any
SAE reports, expedited and periodic safety reports (PSURs), 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
