Medical Director – SERM, Clinical Safety, Pharmacovigilance
Job Description:
- Lead safety evaluation and benefit-risk assessments for assigned products
- Support pharmacovigilance and risk management activities across clinical development and marketed products
- Contribute to regulatory submissions and health authority interactions
- Prepare and review scientifically sound responses to Health Authority Requests for Information (RFIs)
- Analyze and interpret clinical and safety data to support regulatory and business decisions
- Participate in cross-functional safety governance and product safety discussions
- Provide protocol and regulatory support throughout the development lifecycle
- Escalate significant safety concerns and emerging risks when appropriate
Requirements:
- MD or equivalent physician qualification
- Significant experience in clinical development, drug safety, pharmacovigilance, or related pharmaceutical functions
- Experience responding to Health Authority Requests for Information (RFIs)
- Strong understanding of benefit-risk assessment and safety evaluation
- Experience supporting regulatory submissions and regulatory authority interactions
- Excellent scientific writing and communication skills
- Proficiency in English is mandatory
- Ability to work independently in a fast-paced, highly matrixed environment
- Oncology experience is highly desirable but not required
- Experience interacting with FDA, EMA, PMDA, and other global regulatory agencies
- Experience supporting global development programs
Benefits:
- Potential contract extension
