Qualified Person for Pharmacovigilance (QPPV) Oversight

At CliniResource, we provide comprehensive QPPV oversight services to ensure that your organization meets all pharmacovigilance regulatory requirements and maintains the highest standards of drug safety. Our services are designed to support pharmaceutical and biotechnology companies, medical device manufacturers, and other stakeholders in maintaining compliance and optimizing their safety monitoring systems.

Our experienced team can assist you in appointing a Qualified Person Responsible for
Pharmacovigilance (QPPV) who will assume the role of overseeing your entire
pharmacovigilance process. 

This includes:

• Appointment of a QPPV: We ensure the appointed QPPV has the required expertise and qualifications in line with EU Directive 2010/84/EU and ICH E2E guidelines.
• QPPV Management: Our team helps ensure that the QPPV is fully integrated into your organization’s safety processes and is empowered to make decisions about safety monitoring, risk management, and regulatory compliance.

We offer a full range of services to ensure the effective functioning of your pharmacovigilance system under QPPV oversight, ensuring compliance with global pharmacovigilance regulations.

Key Benefits of Our QPPV Oversight Services

• Expert Oversight: We provide you with experienced QPPVs who bring deep knowledge of global regulatory requirements and pharmacovigilance best practices.
• Regulatory Compliance: We ensure your organization is fully compliant with all regulatory requirements across different regions, including the EU, FDA, and other international bodies.
• Efficient Safety Monitoring: Our QPPV oversight ensures effective safety monitoring, timely adverse event reporting, and robust risk management processes, safeguarding both patients and the reputation of your products.
• Proactive Risk Management: We help identify and mitigate potential risks early, reducing the likelihood of product recalls or regulatory penalties.
• Cost Efficiency: By outsourcing QPPV oversight to us, you benefit from expert management without the overhead costs of in-house staffing.
• Audit Readiness: We ensure you are always prepared for regulatory audits and inspections, reducing the likelihood of non-compliance issues and fines.
• Ongoing Training and Support: We provide continuous training and regulatory updates, ensuring your pharmacovigilance teams are always aligned with the latest industry standards.

At CliniResource, we understand the critical role of the QPPV to have direct oversight of end-to-end pharmacovigilance systems for the MAHs. As part of our commitment to
excellence, we extend our QPPV support services to countries where a local contact for pharmacovigilance is a prerequisite, ensuring compliance with evolving regulatory
standards.

Contact us today to learn how we can help you with QPPV oversight services and ensure that your products remain safe and compliant in the global marketplace.