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Leading integrated medical safety and pharmacovigilance strategy, the full-time Medical Safety Lead will oversee clinical safety surveillance, translate preclinical data into clinical safety strategies, and manage external pharmacovigilance providers for a biotech company focused on novel therapeutics.
Key responsibilities: Lead the development and implementation of medical safety strategies across a portfolio of biologics and oral therapeutics Provide medical oversight for clinical safety surveillance, adverse event assessment, and benefit-risk evaluations Establish safety infrastructure and processes to support the organization's clinical portfolio expansionRequired qualificationsMD with clinical training in immunology, inflammation, or a related medical specialty 5-7 years of experience in biotechnology or pharmaceutical medical safety with leadership responsibilities Experience in leading safety strategy through early clinical development, including first-in-human studies Strong understanding of global pharmacovigilance regulations, including FDA, EMA, and ICH guidelines Background in biologics and immune-modulating therapeutics, with relevant experience in antibodies/bispecifics

Also on the board Same function, level within a rung

Level

Manager

Location

New York, NY

Occupation

Medical Scientists, Except Epidemiologists

Industry

Biological Product Manufacturing

Posted

2 days ago

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