*Role can based at our Cambridge, MA or Toronto, Ontario locations. The role can also be remote in the U.S. or Canada.
The Global Head of Drug Safety will be responsible for the strategic implementation, execution, and management of Pharmacovigilance and risk management activities in conjunction with the AVROBIO’s development and future looking commercial activities. They must effectively collaborate cross-functionally at all levels in the organization as well as external safety service providers and regulatory authorities.
The Global Head of Drug Safety will lead and is accountable for providing strategic medical oversight for all pharmacovigilance functions which includes but is not limited to: (1) overseeing and leading the signal assessment and management process in conjunction with the PV team and external vendors (ie CROs) (2) management and mentoring of the drug safety team, (3) product benefit- risk management, (4) oversight of PV Operations within Quality, Compliance and PV Systems Analytic Team functions for investigational and eventually marketed products; (5) address any external questions related to product safety; and ensure proactive safety signaling and timely risk-benefit assessments of safety data. The candidate will play a visible role towards providing safety leadership and advisement in company wide forums and initiatives.