Director of Pharmacovigilance Systems and Operations

Summary

Join Roivant, a biopharmaceutical company, as the Director of Pharmacovigilance Systems and Operations. Lead the development and management of Roivant's safety management infrastructure, working closely with regulatory affairs and drug safety teams. You will oversee safety database systems, collaborate with vendors, develop processes and SOPs, and ensure compliance with regulatory reporting requirements. This role requires extensive experience in drug safety operations, global clinical studies, and implementing safety systems. The ideal candidate is a self-starter, detail-oriented, and comfortable working in a fast-paced environment.

Requirements

• Have an RN, MS, MPH, PharmD or equivalent degree
• Have a minimum of 15 years of drug development experience in the pharmaceutical industry
• Have implemented safety systems, including writing test scripts and acceptance testing
• Be a pro-active, self-motivated, goal oriented individual with demonstrated strong project management skills
• Have experience in global phase 1 early stage programs through phase 3 late stage programs
• Be willing to learn, expand knowledge and role as needed, understanding that there will always be something new to learn, do and develop
• Be able to work in a fast-paced multi-program environment and be able to pivot quickly
• Have experience in global clinical studies and reporting requirements
• Have a strong understanding of PV processes and quality requirements
• Be a highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders, including external vendors, contractors and strategic partners
• Have excellent verbal and written skills, be able to facilitate and engage in open and effective dialogue throughout the company
• Be able to command respect from peers and be capable of highly independent work
• Be a decisive individual with the flexibility and creativity to excel in and contribute to a rapidly growing company

Responsibilities

• Be responsible and accountable for Roivant’s drug safety infrastructure and safety database systems, including validation and testing
• Work with external vendors on safety case processing and systems management
• Oversee and, as needed, develop safety/PV processes and SOPs
• Work with existing drug safety team at Roivant and at subsidiary Vants to insure all drug safety/PV responsibilities are appropriately handled
• Work closely with regulatory affairs at Roivant and/or at the subsidiary Vants to insure all drug safety regulatory reporting requirements are met
• Be responsible for developing and managing any pharmacovigilance agreements with external partners
• Be able to assess clinical study specific safety, whether it is at the study design standpoint or at the level of a specific safety case report
• Handle in-licensing due diligence from a drug safety/PV standpoint
• Function as the drug safety/PV subject matter expert on program and diligence teams
• Keep up to date on changing global regulatory landscape as it applies to drug safety and pharmacovigilance

Preferred Qualifications

Have experience with ArisGlobal LSMV and Veeva Vault systems