Guidelines for Pharmacovigilance Incident Management
1) Purpose
The purpose of this SOP is to establish procedures for the management and reporting of pharmacovigilance incidents and non-serious adverse events.
2) Scope
This SOP applies to all pharmacovigilance personnel involved in incident management, including pharmacovigilance managers, case managers, and safety scientists.
3) Responsibilities
The Incident Management Team is responsible for identifying, assessing, documenting, and reporting pharmacovigilance incidents in compliance with regulatory requirements. The Pharmacovigilance (PV) Manager oversees incident management activities to ensure timely and accurate reporting.
4) Procedure
4.1 Incident Identification and Documentation
- Receive and document pharmacovigilance incidents reported through various sources, including healthcare professionals, consumers, and literature.
- Classify incidents based on severity, clinical relevance, and regulatory reporting requirements.
- Enter incident data into the pharmacovigilance database for further assessment.
4.2 Incident Assessment and Causality Analysis
- Evaluate incidents to determine causality relationship between the pharmaceutical product and the reported event.
- Conduct medical review and analysis of available data to assess the seriousness and potential impact of the incident.
- Document causality assessment findings and decisions.
4.3 Reporting and Communication
- Prepare and submit individual case safety reports (ICSRs) to regulatory authorities according to reporting timelines and requirements.
- Communicate incident findings and updates to relevant stakeholders, including healthcare providers and regulatory agencies.
- Ensure accurate and timely reporting of incidents to support patient safety and regulatory compliance.
4.4 Follow-up and Documentation
- Monitor follow-up activities related to reported incidents, including additional information requests and outcome assessments.
- Update incident 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 incident data and reporting.
- Review incident management processes and identify opportunities for process improvement.
- Participate in training and development activities to enhance incident management competencies.
5) Abbreviations, if any
PV – Pharmacovigilance, SOP – Standard Operating Procedure, ICSR – Individual Case Safety Report
6) Documents, if any
Incident reports, ICSR submissions, 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
