Guidelines for Managing Pharmacovigilance Vendors

1) Purpose

The purpose of this SOP is to outline the procedures for selecting, qualifying, and managing vendors who provide services related to pharmacovigilance activities to ensure compliance with regulatory requirements and company standards.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in the selection, qualification, and management of vendors who provide pharmacovigilance services.

3) Responsibilities

The Vendor Management Officer is responsible for the selection, qualification, and ongoing management of vendors. The Pharmacovigilance (PV) Manager oversees the vendor management process and ensures compliance with this SOP.

4) Procedure

4.1 Vendor Selection

1. Identify the need for vendor services and specify the requirements and scope of work.
2. Develop a list of potential vendors based on their expertise, experience, and reputation in the industry.
3. Conduct a preliminary assessment of each potential vendor to determine their suitability for the required services.

4.2 Vendor Qualification

1. Request detailed information from shortlisted vendors, including their qualifications, experience, and compliance with regulatory requirements.
2. Conduct an on-site audit or remote assessment of the vendor’s facilities and processes to ensure they meet company standards.
3. Evaluate the vendor’s performance history, quality control measures, and ability to deliver the required services.
4. Document the qualification process and make a final decision on vendor selection.

4.3 Contracting

1. Develop a detailed contract that outlines the scope of work, deliverables, timelines, performance standards, and confidentiality requirements.
2. Include provisions for monitoring, reporting, and addressing non-compliance issues in the contract.
3. Ensure the contract is reviewed and approved by legal and compliance departments before finalizing.

4.4 Vendor Monitoring and Management

1. Establish a communication plan to ensure regular and effective communication with the vendor.
2. Monitor the vendor’s performance against the agreed-upon deliverables and performance standards.
3. Conduct periodic reviews and audits of the vendor’s processes and deliverables to ensure ongoing compliance with company standards and regulatory requirements.
4. Address any issues or non-compliance promptly and work with the vendor to implement corrective actions.

4.5 Documentation and Record Keeping

1. Maintain comprehensive records of all vendor management activities, including selection, qualification, contracts, monitoring, and audits.
2. Ensure all documentation is stored securely and is accessible only to authorized personnel.

4.6 Training and Awareness

1. Provide regular training to all PV personnel involved in vendor management on the procedures and best practices outlined in this SOP.
2. Ensure that new employees receive training on vendor management as part of their onboarding process.

4.7 Continuous Improvement

1. Regularly review and update vendor management processes to ensure they remain effective and compliant with regulatory requirements.
2. Implement changes to the vendor management process based on feedback, audit findings, and changes in regulatory requirements.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure

6) Documents, if any

Vendor qualification questionnaires, audit reports, contracts, monitoring reports, training materials.

7) Reference, if any

ICH Guideline for Good Clinical Practice, FDA Guidance for Industry – Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring, EU Guidelines on Good Pharmacovigilance Practices (GVP) Module IV – Pharmacovigilance Audits.

8) SOP Version

Version 1.0