Guidelines for Expedited Pharmacovigilance Reporting

1) Purpose

The purpose of this SOP is to establish standardized procedures for expedited reporting of serious adverse events (SAEs) to regulatory authorities to ensure timely communication and compliance with regulatory requirements.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in the reporting of serious adverse events, including safety specialists, data entry operators, and managers.

3) Responsibilities

The Reporting Team is responsible for preparing and submitting expedited reports. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and internal standards.

4) Procedure

4.1 Identification of Reportable Events

1. Review case reports to identify serious adverse events (SAEs) that meet expedited reporting criteria.
2. Determine the regulatory reporting timelines based on the seriousness and expectedness of the event.
3. Document the identified reportable events and the rationale for expedited reporting.

4.2 Preparation of Expedited Reports

1. Access the pharmacovigilance database and log in using authorized credentials.
2. Open a new report form for the identified SAE or update an existing report as required.
3. Enter the patient information, including age, gender, and relevant medical history.
4. Document the adverse event details, including onset date, symptoms, and severity.
5. Include relevant test results, medical assessments, and concomitant medications.
6. Ensure the causality assessment and seriousness classification are accurately recorded.
7. Review the report for accuracy and