Director of Pharmacovigilance and Drug Safety Operations (Remote)

Roivant Sciences - New York, NY

Full-time - Senior

Remote - New York, NY

Professional, Scientific, and Technical Services

About the position

The Director of PV/Drug Safety Operations at Roivant will oversee the strategic and tactical aspects of drug safety operations, ensuring that all operational requirements for novel drug clinical development are met. This role involves hands-on management of safety systems, infrastructure implementation, and program-level drug safety assessments, requiring a strong understanding of drug safety science and extensive experience in drug development across various clinical phases.

Responsibilities

• Work with external vendors on safety case processing and systems management.
• Develop and implement drug safety/PV infrastructure and systems as necessary.
• Oversee and manage Roivant's safety database system.
• Oversee safety processes and SOPs.
• Collaborate with the existing drug safety team and subsidiary Vants to ensure all drug safety responsibilities are handled appropriately.
• Work closely with regulatory affairs to meet all drug safety regulatory reporting requirements.
• Develop and manage pharmacovigilance agreements with external partners.
• Assess clinical study-specific safety from both study design and safety case report perspectives.
• Handle in-licensing due diligence from a drug safety/PV standpoint.
• Function as the drug safety/pharmacovigilance subject matter expert on program and diligence teams.
• Stay updated on the changing regulatory landscape related to drug safety and pharmacovigilance.

Requirements

• RN, MS, MPH, PharmD or equivalent degree.
• Minimum 15 years of drug development experience in the pharmaceutical industry.
• Experience in phase 1 early stage programs through phase 3 late stage programs.
• Experience in global clinical studies and reporting requirements.
• Strong understanding of PV processes and quality requirements.
• Highly collaborative team player with excellent verbal and written communication skills.
• Experience with ArisGlobal LSMV and Veeva Vault systems is preferred.
• Ability to command respect from peers and work independently as well as in a team.

Nice-to-haves

• Experience with ArisGlobal LSMV and Veeva Vault systems is preferred.