Sr Medical Manager PSS
About This Gig
Summary of Responsibilities: Responsible for medical review of serious adverse events and adverse events of special interest from clinical trials in support of drug safety activities for clients. When applicable, responsible for preparation and medical review of Aggregate Reports required by global regulatory agencies for review of safety information for assigned products, when authorized to perform this function on behalf of a client. When applicable, responsible for signal detection and evaluation activities and preparation and submission of Ad Hoc Reports reviewing specific safety issues to the global regulatory agencies for assigned products, when authorized to perform this function on behalf of a client. Participates in training opportunities to advance knowledge of pharmacovigilance as it relates to drug/product development and drug/product marketing utilizing good clinical practice guidelines. Provides medical/safety expertise to project teams, including communicating informati
About the Seller
Fortrea
on Himalayas