The Role of the QPPV in Ensuring Global Pharmacovigilance Compliance

What is a Qualified Person for Pharmacovigilance (QPPV)?

The Qualified Person for Pharmacovigilance (QPPV) is a regulatory requirement in the European Union (EU), where pharmaceutical companies marketing drugs in the region must designate a QPPV to oversee all pharmacovigilance activities. This individual is responsible for ensuring that the company complies with all safety monitoring obligations as per EU Directive 2001/83/EC and Regulation (EC) No 726/2004.

At Viltis, we offer outsourced QPPV services to ensure that your company remains compliant with the EU’s strict pharmacovigilance standards. By outsourcing QPPV responsibilities, pharmaceutical companies can benefit from expert oversight while streamlining internal operations and focusing on core business activities.

Key Responsibilities of a QPPV:

1. Oversight of the Pharmacovigilance System: The QPPV is responsible for establishing and maintaining the company’s Pharmacovigilance System Master File (PSMF), a detailed document that outlines the company’s pharmacovigilance processes and compliance measures.

2. Continuous Safety Monitoring: The QPPV must ensure that the company monitors the safety of all its marketed products and that safety concerns are identified, assessed, and managed promptly. This includes managing safety signals, reviewing individual case safety reports (ICSRs), and overseeing risk management activities.

3. Regulatory Submissions: The QPPV is responsible for ensuring that Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and other key regulatory documents are prepared and submitted on time to the European Medicines Agency (EMA) and other regulatory bodies.

4. Communication with Regulatory Authorities: The QPPV serves as the main point of contact between the pharmaceutical company and regulatory authorities such as the EMA and national competent authorities. This individual is responsible for providing prompt and accurate responses to safety-related queries and regulatory concerns.

5. Crisis Management: In the event of a safety crisis, such as a recall or significant adverse event discovery, the QPPV is responsible for implementing appropriate actions, including safety warnings, labeling changes, or product withdrawals.

Outsourcing QPPV Services: Key Benefits

1. Cost Efficiency: By outsourcing the QPPV role to Viltis, pharmaceutical companies can reduce the costs associated with hiring and training an internal QPPV while ensuring full compliance with EU regulations.

2. Expertise and Flexibility: Viltis’ QPPV experts have extensive experience in managing complex pharmacovigilance systems and navigating the ever-evolving regulatory landscape in the EU. Our team is flexible and can adapt to the unique needs of your pharmacovigilance operations.

3. 24/7 Availability: One of the requirements for a QPPV is to be available at all times to address urgent safety concerns. Outsourcing ensures that this responsibility is covered by a dedicated team, reducing the burden on internal resources.