EU Licensed QPPV

Job Summary

Responsible for establishing and maintaining pharmacovigilance systems, the full-time EU Licensed QPPV will ensure compliance with regulatory requirements, oversee safety aspects of medicinal products, and provide timely information to competent authorities while working remotely.

Key responsibilities

• Establish and maintain a system for collecting and collating information on suspected adverse reactions
• Respond promptly to requests from competent authorities regarding additional information for medicinal product evaluations
• Oversee safety aspects of the company's medicinal products, including safety profiles and emerging safety concerns

Required qualifications

• Life-science education background in Medicine (human or veterinary) or Pharmacy preferred
• Solid knowledge of pharmacovigilance system operations and functions
• Strong understanding of global regulations and best practices in safety processing and reporting
• Proven operational and managerial skills from leading previous projects or functions
• Extensive experience in a pharmacovigilance role, with profound experience as a QPPV