Senior Medical Director, Drug Safety & Pharmacovigilance
Company: Beacon Hill Staffing Group
Location: Cambridge
Posted on: June 20, 2022
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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
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