Director of Pharmacovigilance and Drug Safety Operations

3 days ago

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Roivant Sciences

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Description

• Roivant’s mission is to systematically reduce the time, cost, and risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients and their families. • The Director of PV/Drug Safety Operations will provide the strategic and tactical oversight for Roivant’s drug safety operations and handle program level drug safety/PV activities. • This position will work closely with the existing drug safety team and the head of regulatory affairs and drug safety to insure all aspects of drug safety operational requirements for novel drug clinical development are managed.

Requirements

• RN, MS, MPH, PharmD or equivalent degree • Minimum 15 years of drug development experience in the pharmaceutical industry • Must have experience in phase 1 early stage programs through phase 3 late stage programs • Must have experience in global clinical studies and reporting requirements • Strong understanding of PV processes and quality requirements • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders, including external vendors, contractors and strategic partners • Excellent verbal and written skills, allows for an open and effective dialogue throughout the company. • Experience with ArisGlobal LSMV and Veeva Vault systems is preferred • Must be able to command respect from peers and capable of highly independent work as well as being a team player and role model. • Must be a highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company. • Requires proven ability to manage multiple projects.