Full-Time Qualified Person Responsible for Pharmacovigilance (EU/UK)

The EU QPPV is responsible for:

1. Establishing and maintaining a system which ensures that information about all suspected adverse reactions reported to company personnel and medical representatives is collected and collated for accessibility within the Community.
2. Ensuring prompt and full responses to requests from CAs for additional information necessary for evaluating a medicinal product's benefits and risks.
3. Providing CAs with relevant information for benefit-risk evaluations, including planned post-authorization safety studies.
4. Maintaining continuous availability to CAs in Member States, the Agency, and the MAH, ensuring adequate backup procedures.
5. Overseeing the safety aspects of the company's medicinal products, including profiles, emerging safety concerns, marketing authorization conditions/obligations, and safety-related commitments and findings from company studies/programs.

Qualifications:

• Life-science education background (Medicine or Pharmacy preferred)
• Solid knowledge of PV systems and functions
• Strong knowledge of global regulations, standards, and best practices regarding safety processing, reporting, surveillance, and pharmaceutical industry compliance.
• Strong operational and managerial skills demonstrated by leading previous projects/functions.
• Profound experience in a PV role as QPPV
• Strong oral and written English communication skills

What is the last date for applying to the job?

Which countries are accepted for this remote job?