Guidelines for Pharmacovigilance Medical Inquiry Response

1) Purpose

The purpose of this SOP is to establish standardized procedures for responding to medical inquiries related to pharmacovigilance.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in responding to medical inquiries, including medical information specialists, pharmacovigilance officers, and pharmacovigilance managers.

3) Responsibilities

The Medical Inquiry Response Team is responsible for providing accurate and timely responses to medical inquiries from healthcare professionals, consumers, and regulatory authorities. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and internal standards.

4) Procedure

4.1 Receipt and Logging of Medical Inquiries

1. Receive medical inquiries via phone, email, or other communication channels.
2. Log each inquiry in a dedicated tracking system or database.
3. Assign an inquiry number for tracking purposes.

4.2 Review and Assessment of Inquiry

1. Assign inquiries to qualified medical information specialists or pharmacovigilance officers for review.
2. Review the inquiry details, including the nature of the inquiry, product information, and relevant safety data.
3. Assess the urgency and complexity of the inquiry to prioritize response times.

4.3 Preparation of Response

1. Gather all necessary information and resources to formulate an accurate response.
2. Consult internal databases, product information, and regulatory guidelines as needed.
3. Ensure the response is comprehensive, accurate, and in compliance with regulatory requirements.

4.4 Drafting and Review of