Guidelines for Pharmacovigilance Seriousness Assessment
1) Purpose
The purpose of this SOP is to provide guidelines for assessing the seriousness of adverse events reported in pharmacovigilance to determine appropriate regulatory reporting and risk management actions.
2) Scope
This SOP applies to personnel responsible for pharmacovigilance case assessment and seriousness determination within the Pharmacovigilance (PV) department.
3) Responsibilities
The Pharmacovigilance (PV) Medical Reviewer is responsible for assessing the seriousness of adverse events. PV Quality Assurance personnel ensure adherence to seriousness assessment procedures.
4) Procedure
4.1 Seriousness Criteria
- Define seriousness criteria based on regulatory guidelines (e.g., ICH E2A), including outcomes such as death, life-threatening, hospitalization, disability, congenital anomaly, and other significant medical events.
- Evaluate adverse events reported in pharmacovigilance against seriousness criteria to determine if an event meets the definition of serious.
4.2 Medical Review
- Conduct medical review of adverse event reports to assess clinical significance, severity, and potential impact on patient safety.
- Consider relevant medical information, including patient history, concomitant medications, and underlying medical conditions, in seriousness assessment.
4.3 Documentation
- Document seriousness assessment findings, including rationale for seriousness determination and supporting clinical evidence.
- Record seriousness assessment outcomes in pharmacovigilance case management systems or databases according to standard operating procedures.
4.4 Reporting Obligations
- Classify adverse events as serious or non-serious based on seriousness assessment findings.
- Ensure timely and accurate reporting of serious adverse events to regulatory authorities and marketing authorization holders (MAHs) as required by pharmacovigilance regulations.
4.5 Quality Assurance Review
- Subject seriousness assessments to quality assurance review to verify consistency, accuracy, and compliance with seriousness criteria and regulatory requirements.
- Address feedback and recommendations from PV Quality Assurance personnel to improve seriousness assessment practices.
4.6 Training and Competency
- Provide training to PV Medical Reviewers and PV personnel involved in seriousness assessment on seriousness criteria, clinical evaluation techniques, and regulatory reporting obligations.
- Assess competency of PV staff through periodic evaluations and training assessments to ensure proficiency in seriousness assessment.
4.7 Continuous Improvement
- Regularly review and update seriousness assessment procedures based on feedback, regulatory changes, and quality assurance findings.
- Implement improvements to seriousness assessment processes to enhance consistency, efficiency, and accuracy in pharmacovigilance case evaluation.
5) Abbreviations, if any
PV – Pharmacovigilance, SOP – Standard Operating Procedure, ICH – International Conference on Harmonization, MAH – Marketing Authorization Holder
6) Documents, if any
Seriousness assessment criteria, seriousness assessment forms, training materials.
7) Reference, if any
ICH Guideline for Good Clinical Practice (E6), FDA Guidance for Industry – Pharmacovigilance Responsibilities of Marketing Authorization Holders (MAHs), EU Guidelines on Good Pharmacovigilance Practices (GVP) Module VI – Management and Reporting of Adverse Reactions to Medicinal Products.
8) SOP Version
Version 1.0