SOP for Pharmacovigilance Risk Communication

Guidelines for Pharmacovigilance Risk Communication

1) Purpose

The purpose of this SOP is to outline procedures for communicating risks associated with pharmaceutical products in pharmacovigilance.

2) Scope

This SOP applies to all pharmacovigilance personnel responsible for risk communication, including pharmacovigilance managers, safety scientists, and communication specialists.

3) Responsibilities

The Risk Communication Team is responsible for assessing, preparing, and disseminating risk communication materials to healthcare professionals, patients, and other stakeholders. The Pharmacovigilance (PV) Manager oversees risk communication activities to ensure accurate and timely dissemination of safety information.

4) Procedure

4.1 Risk Assessment and Communication Planning

Assess identified risks associated with pharmaceutical products based on pharmacovigilance data, clinical trials, and regulatory findings.
Collaborate with medical and regulatory affairs teams to determine appropriate risk communication strategies and target audiences.
Develop a risk communication plan outlining objectives, key messages, channels, and timelines for communication activities.

4.2 Preparation of Risk Communication Materials

Prepare risk communication materials, including safety alerts, Dear Healthcare Professional letters, patient information leaflets, and press releases.
Ensure risk communication materials are accurate, clear, and compliant with regulatory requirements.
Review and approve materials with input from medical, regulatory, and legal stakeholders.

4.3 Dissemination of Risk Information

Distribute risk communication materials to healthcare professionals, patients, regulatory authorities, and other relevant stakeholders through appropriate channels.
Monitor receipt and acknowledgment

of risk communication by targeted audiences.

Respond to inquiries and provide additional information as needed to address stakeholder concerns.

4.4 Follow-up and Evaluation

Monitor the impact of risk communication activities on stakeholder awareness and behavior.
Evaluate the effectiveness of risk communication materials and strategies through feedback and metrics.
Update risk communication materials and strategies based on evaluation findings and emerging safety data.

4.5 Crisis Communication Management

Develop and implement crisis communication plans for managing unexpected safety issues or public concerns.
Coordinate with corporate communication and public relations teams to maintain transparency and manage reputational risks.
Ensure alignment of crisis communication activities with regulatory reporting and compliance requirements.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure

6) Documents, if any

Risk communication plans, safety alerts, Dear Healthcare Professional letters, patient information leaflets, crisis communication plans.

7) Reference, if any

EU Good Pharmacovigilance Practices (GVP) Module V – Risk Management Systems, FDA Guidance for Industry – Risk Evaluation and Mitigation Strategies (REMS).

8) SOP Version

Version 1.0