Senior Consultant Pharmacovigilance will support clients in Pharmacovigilance and compliance with global and local regulatory requirements, and prepare, review, and oversee PV documentation in registration and post-registration processes.
Requirements
- Higher education in pharmacy, medicine, biotechnology, or related biological sciences
- Minimum 7 years of experience in Pharmacovigilance/Drug Safety
- Good knowledge of global regulations and PV guidelines (ICH, EMA, FDA, GVP)
- Experience in global PV processes and systems (PSUR/PBRER, RMP, ICSR, EudraVigilance, XEVMPD)
- Experience in audits and support for inspections
- Project management skills and ability to cooperate with clients
- Fluent English language skills (minimum C1 level) and Polish language skills
Benefits
- Comprehensive benefits package
- Medical care
- Cafeteria benefits card with a sports card
- Group life insurance
- Referral program