Regulatory Affairs and Pharmacovigilance Specialist

Job Summary

A company is looking for a CEE Regulatory Affairs Specialist and Pharmacovigilance Officer.

Key Responsibilities

• Prepare regulatory applications and supporting documentation for marketing authorizations and product recalls
• Monitor local and EU regulatory legislation and provide consultancy to contractual partners
• Collect and manage safety data, including Individual Case Safety Reports (ICSRs) and Periodic Safety Update Reports (PSURs)

Required Qualifications and Education

• B.Sc./B.A. or higher degree in medicine, pharmacy, dental medicine, medical biochemistry, veterinary medicine, or life/nature science
• At least two years of experience in regulatory affairs
• Advanced knowledge of local legislation for regulatory activities
• Experience with European and national regulatory submissions and agency interactions
• No previous experience in pharmacovigilance is required