virtual vocationsNew York, NY
Medical Safety Lead
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