Patient Safety Senior Medical Director

Job Description General Summary: The Patient Safety Senior Medical Director will provide leadership for all safety and risk management activities for assigned products, pre- and/or post-approval. This role will lead Risk Management activities, pre-, peri- and post-approval (as applicable) for assigned compound(s) and will provide relatively autonomous leadership of periodic (aggregate) safety report, signaling, labelling and DST activities for assigned compounds, as well as participate in individual case medical review. This role will lead representation, as safety lead, on clinical teams/programs, regulatory filings and submissions and other intra and/or inter-departmental activities and initiatives, including process/SOP development, audits and inspections.…