Medical Director – Clinical Safety & Pharmacovigilance

• 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
• Provide medical leadership for safety evaluation, benefit-risk assessment, and risk management of products in clinical development and post-marketing settings

• 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

• 1-Year Contract with potential extension
• Remote work arrangement
• Availability to work within U.S. and/or U.K. business time zones