Senior Director, Head of Medical Review

Role: Senior Director, Head of Medical Review, responsible for overseeing global medical assessment of individual case safety reports for investigational and marketed products across all therapeutic areas. Responsibilities include providing strategic leadership for medical review activities, ensuring compliance with international regulations (ICH, FDA, EMA, MHRA), managing a team of medical review physicians and vendors, developing SOPs and training materials, and collaborating with cross-functional stakeholders such as safety, quality, and clinical teams. The role involves maintaining high standards for safety assessment, supporting regulatory inspections, and implementing process improvements. Requirements: Medical degree (or equivalent), 15+ years in pharmaceutical or healthcare industry, with at least 3 years of clinical experience and extensive pharmacovigilance expertise, including medical review of safety data. Strong knowledge of global drug safety regulations, clinical development, and health care business acumen is essential. Preferred: USMLE/ECFMG/COMLEX-USA/FLEX, international work experience, and leadership in matrix teams. High-Value: Focus on pharmacovigilance, medical review, regulatory compliance, global collaboration, and a hybrid work setting in Boston, MA.