Senior Medical Director, Drug Safety & Pharmacovigilance

Company: Beacon Hill Staffing Group
Location: Cambridge
Posted on: June 20, 2022

Job Description:

Senior Medical Director, Drug Safety & PharmacovigilanceThis is both a strategic and hands-on role. Responsibilities:--- Develop strategy for Safety surveillance for the clinical trials across platform in collaboration with clinical development team--- Manage safety signals and lead cross-functional safety management team--- Lead DSPV in various cross-functional teams (e.g., Clinical program teams)--- Perform medical review of SAEs, SUSARs and aggregate safety data from all sources in collaboration with CRO medical monitors--- Lead the development of safety risk management plans, IND annual safety reports--- Develop and update RSIs for IBs--- Develop and contribute for BLA safety deliverables and regulatory responses--- Develop and contribute for safety surveillance SOPs, participate in PV audit and inspections--- Collaborate with PV Operation on DSPV functional deliverables--- Supervise, coach and mentor safety/risk management scientistsRequired Skills:Experienced safety physician with -8-10 years of experience in PV/DS Clinical Practicing experience prior to entering industryHands-on experience of the good pharmacovigilance practices and international regulatory requirements such as EMA/FDA/ICH guidelinesPrior experience working as a Safety Physician responsible for gene therapy or biologics

Keywords: Beacon Hill Staffing Group, Cambridge , Senior Medical Director, Drug Safety & Pharmacovigilance, Executive , Cambridge, Massachusetts