Director of Pharmacovigilance Systems and Operations (Remote)

Roivant is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant advances its pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize medicines and technologies. Since its inception in 2014, Roivant has achieved the following critical milestones in support of its vision: built over 20 Vants; 11 consecutive positive Phase 3 trials; 8 FDA approvals; 5 successful IPOs; >$6B in capital raised; >$10B in global pharma partnerships and proceeds; and continued pipeline expansion across various modalities and therapeutic areas through in-licensing and acquisition of novel product candidates and technology platforms.  In addition to a robust clinical stage pipeline, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business.

As the centralized engine for innovation and development the Roivant R&D team is responsible for: 1) working hand in hand with Business Development to establish the scientific rationale and creating/underwriting a development strategy for in-licensing opportunities, with a focus on oncology, immunology and rare diseases; 2) providing tactical and strategic R&D support to stand up new portfolio companies (Vants) and advance development efforts across the portfolio.  

To learn more about our story and company culture, please visit us at https://roivant.com/

Position Summary:

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.

Responsibilities:

• Responsible and accountable for Roivant’s drug safety infrastructure and safety database systems, including validation and testing
• Works with external vendors on safety case processing and systems management
• Oversees and as needed, develops safety/PV processes and SOPs
• Works with existing drug safety team at Roivant and at subsidiary Vants to insure all drug safety/PV responsibilities are appropriately handled
• Works closely with regulatory affairs at Roivant and/or at the subsidiary Vants to insure all drug safety regulatory reporting requirements are met
• 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
• Functions as the drug safety/PV subject matter expert on program and diligence teams
• Keeps up to date on changing global regulatory landscape as it applies to drug safety and pharmacovigilance

Skills, Qualifications and 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

Roivant Sciences provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

We will not accept unsolicited resumes nor outreach from agencies. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. Thanks!