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 Response

1. Draft a response that addresses the specific inquiry and provides relevant medical information.
2. Review the drafted response for accuracy, clarity, and completeness.
3. Seek input from medical experts or regulatory affairs as necessary.

4.5 Response Submission and Follow-Up

1. Submit the response to the requester within the specified timeframe.
2. Track responses and ensure timely follow-up on any outstanding inquiries.
3. Document all communication and correspondence related to the medical inquiry.

4.6 Documentation and Record Keeping

1. Maintain detailed records of all medical inquiries and responses.
2. Ensure all documentation is securely stored and easily accessible for audits and inspections.

4.7 Quality Control

1. Conduct regular quality control checks on the inquiry response process to ensure accuracy and consistency.
2. Address any discrepancies or errors identified during quality control checks promptly.
3. Document all quality control activities and any corrective actions taken.

4.8 Training and Communication

1. Provide training to medical information specialists and pharmacovigilance officers on inquiry handling procedures and regulatory requirements.
2. Communicate updates to inquiry response procedures and guidelines to ensure consistency in practices.
3. Report any issues or challenges encountered during the inquiry response process to the PV Manager.

5) Abbreviations, if any

PV – Pharmacovigilance

6) Documents, if any

Medical inquiry logs, response templates, correspondence records.

7) Reference, if any

ICH E2E Pharmacovigilance Planning, EU Good Pharmacovigilance Practices (GVP) Module VI.

8) SOP Version

Version 1.0