Offer summary
Qualifications:
MD degree or equivalent, General practitioner license, Minimum 3 years in pharmacovigilance, Strong knowledge of FDA and EMA regulations, Experience with NDA/BLA submissions.
Key responsabilities:
- Lead safety profile determination and risk mitigation of products
- Collaborate on clinical documents and regulatory submissions
- Chair the cross-functional Product Safety Group
- Perform medical review and signal management activities
- Guide and train safety physicians on surveillance activities