Guidelines for Pharmacovigilance Data Analysis and Reporting

1) Purpose

The purpose of this SOP is to establish procedures for conducting pharmacovigilance data analysis and preparing accurate and timely safety reports to regulatory authorities and stakeholders.

2) Scope

This SOP applies to personnel involved in pharmacovigilance data analysis, reporting, and submission within the Pharmacovigilance (PV) department.

3) Responsibilities

The Pharmacovigilance (PV) Data Analyst is responsible for conducting data analysis and preparing pharmacovigilance reports. PV Medical Reviewers and PV Quality Assurance personnel are responsible for reviewing and approving reports.

4) Procedure

4.1 Data Analysis

1. Retrieve pharmacovigilance data from the pharmacovigilance database or case management system for analysis, including adverse event reports, safety signals, and aggregate data.
2. Conduct descriptive and quantitative data analysis to identify trends, patterns, and potential safety signals associated with medicinal products.

4.2 Signal Detection and Evaluation

1. Perform signal detection activities to assess potential safety concerns based on data analysis results, including statistical analyses and data mining techniques.
2. Evaluate identified signals through medical review and clinical assessment to determine clinical relevance and potential impact on patient safety.

4.3 Report Preparation

1. Prepare pharmacovigilance reports, including periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBRERs), and ad-hoc safety reports.
2. Ensure reports are accurate, comprehensive, and compliant with regulatory requirements and internal pharmacovigilance procedures.

4.4 Regulatory Submission

1. Compile and format pharmacovigilance reports for submission to regulatory authorities, including FDA, EMA, and other global health agencies, within specified timelines.
2. Coordinate with Regulatory Affairs (RA) to facilitate timely submission of pharmacovigilance reports and responses to regulatory inquiries.

4.5 Quality Assurance Review

1. Subject pharmacovigilance reports to quality assurance review to verify accuracy, completeness, and adherence to regulatory requirements and internal standards.
2. Address feedback and recommendations from PV Quality Assurance personnel to improve report quality and compliance.

4.6 Documentation and Record Keeping

1. Maintain documentation of pharmacovigilance data analysis, report preparation, and submission activities, including data analysis plans, report templates, and submission records.
2. Archive pharmacovigilance reports and associated documentation in accordance with pharmacovigilance documentation management procedures and regulatory guidelines.

4.7 Continuous Improvement

1. Regularly assess and update pharmacovigilance data analysis and reporting procedures based on feedback, regulatory changes, and performance evaluations.
2. Implement process improvements to enhance data analysis techniques, reporting efficiency, and report quality in pharmacovigilance.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, PSUR – Periodic Safety Update Report, PBRER – Periodic Benefit-Risk Evaluation Report, FDA – Food and Drug Administration, EMA – European Medicines Agency

6) Documents, if any

Data analysis plans, report templates, submission records, quality assurance checklists.

7) Reference, if any

ICH Guideline for Good Clinical Practice, FDA Guidance for Industry – Pharmacovigilance Responsibilities of Marketing Authorization Holders (MAHs), EU Guidelines on Good Pharmacovigilance Practices (GVP) Module IX – Signal Management.

8) SOP Version

Version 1.0