Offer summary
Qualifications:
MD, MBBS, MD-PhD or equivalent medical degree, 5+ years in Drug Safety & Pharmacovigilance, Strong understanding of pharmacovigilance regulations, Experience with registrational clinical studies, Prior regulatory experience with IND and NDA/BLA preferred.
Key responsabilities:
- Lead pharmacovigilance strategy and activities
- Conduct signal detection and safety reviews
- Manage Safety Monitoring Team meetings
- Oversee aggregate reports and regulatory queries
- Develop and manage drug safety budget