EU Licensed Pharmacovigilance Officer

Job Summary

As a full-time, home-based EU Licensed Pharmacovigilance Officer, the Qualified Person Responsible for Pharmacovigilance (QPPV) will manage the establishment and maintenance of systems for collecting adverse reaction information, respond promptly to regulatory authorities, and oversee the safety aspects of medicinal products.

Key responsibilities

• Establish and maintain a system for collecting and collating information on suspected adverse reactions
• Respond fully and promptly to requests from regulatory authorities for additional information regarding 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 related to safety processing and reporting
• Proven operational and managerial skills, demonstrated by leading previous projects or functions
• Significant experience in a pharmacovigilance role, with profound experience as a QPPV