Director of Pharmacovigilance Systems and Operations

February 15

🗽 New York – Remote

Although this job is listed in New York, this company may be open to hiring remote in other states.

⏰ Full Time

🔴 Lead

⚙️ Operations

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Roivant Sciences

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Roivant aims to improve health by rapidly delivering innovative medicines and technologies to patients. We do this by building Vants – nimble, entrepreneurial biotech and healthcare technology companies with a unique approach to sourcing talent, aligning incentives, and deploying technology.

201 - 500 employees

📋 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 Pharmacovigilance Systems and Operations will be the lead for Roivant’s safety management infrastructure, developing the strategic and tactical management of this infrastructure. • This position will work closely with the head of regulatory affairs and drug safety to insure all aspects of drug safety system needs for novel drug clinical development are managed. • Additionally, this individual in conjunction with the drug safety team will also support Roivant’s drug safety operations and be able to handle program level drug safety/PV activities. • A successful candidate is a self-starter, pro-active, detail oriented, creative thinker, who understands and has implemented safety management systems (e.g. Aris Global, Argus, others), has done user acceptance testing and written test scripts, has clear experience in managing multiple vendors and internal stakeholders to insure seamless drug safety operations and demonstrate clear leadership in developing and managing safety systems. • This individual must have experience in overall drug safety operations and drug development from early phase 1 to late phase 3 clinical studies and have worked in supporting global programs within a highly cross-functional team structure. • Finally, the candidate needs to be one who has functioned in a small fast paced environment and is comfortable in pivoting from program to program with strong time management skills.

🎯 Requirements

• RN, MS, MPH, PharmD or equivalent degree • Minimum 15 years of drug development experience in the pharmaceutical industry • Experience with ArisGlobal LSMV and Veeva Vault systems is strongly preferred • Has implemented safety systems, including writing test scripts and acceptance testing • Must be a pro-active, self-motivated, goal oriented individual with demonstrated strong project management skills • Must have experience in global phase 1 early stage programs through phase 3 late stage programs • Willing to learn, expand knowledge and role as needed, understanding that there will always be something new to learn, do and develop • Able to work in a fast-paced multi-program environment and be able to pivot quickly • 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, able to facilitate and engage in open and effective dialogue throughout the company • Must be able to command respect from peers and capable of highly independent work • Must be a decisive individual with the flexibility and creativity to excel in and contribute to a rapidly growing company