Senior Medical Director, Pharmacovigilance and Safety
Abata TherapeuticsFull Time
Senior (5 to 8 years)
Candidates must possess an advanced medical or scientific degree such as an MD or PhD, with expertise in global pharmacovigilance regulations and benefit-risk frameworks. Required skills include strong knowledge of clinical development, regulatory affairs, and medical affairs, along with proven ability to lead safety strategies through product approvals and post-marketing phases. Exceptional leadership, team-building, organizational development, and strategic vision are essential, as are excellent communication and presentation skills at executive and board levels. Experience with advanced safety data analysis and interpretation methods, and the ability to drive innovation while maintaining regulatory compliance are also required.
The Head of Pharmacovigilance Sciences will develop and implement a comprehensive safety strategy aligned with corporate objectives, and drive innovation in pharmacovigilance through advanced analytics and real-world evidence. Responsibilities include leading global safety governance frameworks and decision-making processes, representing safety interests at the executive level, and serving as the principal safety expert in regulatory interactions. The role involves overseeing safety-related submissions, inspections, and communications with regulatory authorities, building and mentoring a high-performing team of safety professionals, and fostering cross-functional collaboration. Additionally, the position requires championing innovative approaches to safety signal detection and evaluation, representing the organization in industry groups and scientific forums, and advancing the integration of genomics, biomarkers, and digital health into safety science.