Director, Drug Safety/Pharmacovigilance Operations
The Director, Drug Safety/Pharmacovigilance Operations will be responsible for the implementation, execution, and management of Pharmacovigilance and risk management activities in conjunction with the AVROBIO’s development and future looking commercial activities. The individual must effectively collaborate cross-functionally at all levels in the organization as well as external safety service providers in partnership with regulatory authorities.
The Director, Drug Safety /PV Operations will lead and is accountable for providing oversight for pharmacovigilance functions which includes but is not limited to: (1) overseeing and facilitating the signal assessment and management process in conjunction with the PV team and external vendors including CROs and scientific consultants (2) management and mentoring of the drug safety operations team- as this team is built in the future (3) product benefit- risk management, (4) oversight of PV Operations and PV Systems Analytic Team functions for investigational and eventually marketed products; (5) ensure proactive safety signaling and timely risk-benefit assessments of safety data. The candidate will play a visible role towards providing safety operations leadership and advisement in trial program and platform initiatives.
The position will report directly into the SVP, Head of Medical and Drug Safety.