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 appropriateRequirements:

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 programsBenefits:

Potential contract extension .