Key Considerations in the Outsourcing of Pharmacovigilance Services
Q.F. Milagros Consuelo Arista Arévalo
QA Specialist & Pharmacovigilance and Technovigilance Coordinator
SCR Consulting Peru
The outsourcing of pharmacovigilance services is an increasingly utilized strategy by pharmaceutical companies to optimize resources and ensure regulatory compliance. However, this practice must be conducted under strict quality standards and established regulations. The Good Pharmacovigilance Practices Manual (Ministerial Resolution No. 1053-2020-MINSA) outlines the guidelines and conditions that companies must meet when subcontracting these services to protect public health and ensure the quality of drug surveillance.
- Regulatory Compliance
The outsourced company must fully comply with the provisions of the Good Pharmacovigilance Practices Manual and current national regulations. Failure to meet these requirements may result in regulatory sanctions and compromise patient safety.
- Capabilities of the Outsourced Provider
- Technical Requirements: The contracted company must have proven experience in pharmacovigilance, with trained personnel and documented processes to ensure the quality of its services.
- Infrastructure: It must have appropriate technological tools for monitoring, analyzing, and reporting adverse events, ensuring the integrity and confidentiality of information.
- Clear Responsibilities
- Outsourcing Contract: It is essential that the contract between both parties clearly defines the responsibilities and obligations of each.
- Supervision and Control: The contracting company remains the final responsible entity for pharmacovigilance regarding its products and must establish monitoring and audit mechanisms to ensure compliance with established standards.
- Confidentiality
The service provider must guarantee the protection of patients’ personal data and the confidentiality of information related to pharmaceutical products, preventing any misuse of such data.
- Auditing and Monitoring
The contracting company must establish audit and supervision mechanisms to periodically evaluate the performance of the outsourced provider. It is advisable to use evaluation formats to measure service quality and ensure compliance with regulatory requirements.
- Training and Education
Personnel involved in pharmacovigilance must receive continuous training to stay updated on regulations and best practices. The contracting company should verify that the outsourced provider has adequate training programs for its team.
- Service Continuity
To avoid interruptions in pharmacovigilance activities, the outsourcing contract must include contingency plans for potential operational failures. Additionally, any modification or transfer of activities to a third party must be reported to CENAFYT for validation and registration.
Conclusion
Outsourcing pharmacovigilance services is a viable alternative for optimizing processes and meeting regulatory requirements. However, it must be strategically implemented to ensure regulatory compliance, service quality, and patient safety. At SCR Consulting, we provide specialized advisory services to ensure that pharmacovigilance outsourcing is carried out under the highest quality standards and regulatory compliance.