Guidelines for Pharmacovigilance Contract Management

1) Purpose

The purpose of this SOP is to establish procedures for the management of contracts related to pharmacovigilance activities, ensuring compliance with regulatory requirements and company policies.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in the negotiation, execution, and management of contracts with vendors, partners, and service providers for pharmacovigilance activities.

3) Responsibilities

The Contract Manager is responsible for overseeing the contract management process. The Pharmacovigilance (PV) Manager ensures that all PV personnel comply with this SOP.

4) Procedure

4.1 Contract Planning and Preparation

1. Identify the need for a contract based on pharmacovigilance activities and requirements.
2. Define the scope of work, deliverables, timelines, and performance metrics for the contract.
3. Establish clear objectives and expectations for the contract.

4.2 Contract Negotiation

1. Select potential contractors or service providers based on their capabilities, experience, and compliance with regulatory requirements.
2. Negotiate terms and conditions, including pricing, payment schedules, deliverables, warranties, indemnities, and liabilities.
3. Ensure that all negotiated terms align with company policies and regulatory requirements.

4.3 Contract Execution

1. Obtain necessary approvals from legal, compliance, and other relevant departments before finalizing the contract.
2. Ensure that all parties involved sign the contract and agree to its terms and conditions.
3. Distribute copies of the executed contract to all relevant parties and maintain a master copy in a secure location.

4.4 Contract Performance Monitoring

1. Establish a monitoring plan to track the performance of the contract and ensure adherence to agreed-upon timelines and deliverables.
2. Conduct regular reviews and assessments of contract performance against predefined metrics.
3. Address any issues or deviations from the contract terms promptly and work with the contractor to implement corrective actions.

4.5 Contract Renewal and Termination

1. Evaluate the need for contract renewal based on performance reviews, changes in regulatory requirements, and business needs.
2. Negotiate renewal terms or initiate termination procedures as necessary.
3. Ensure that all parties are notified in advance of contract expiration or termination.

4.6 Documentation and Record Keeping

1. Maintain comprehensive records of all contract management activities, including planning, negotiation, execution, monitoring, and renewal/termination.
2. Ensure all contract-related documentation is stored securely and is accessible only to authorized personnel.

4.7 Training and Awareness

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

4.8 Continuous Improvement

1. Regularly review and update contract management processes to ensure they remain effective and compliant with regulatory requirements.
2. Implement changes to the contract 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

Contract templates, negotiation records, executed contracts, performance 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 V – Risk Management Systems.

8) SOP Version

Version 1.0