Director of Pharmacovigilance and Drug Safety Operations
4 weeks ago
Job Summary:
The Director of Pharmacovigilance and Drug Safety Operations will provide strategic and tactical oversight for Roivant's drug safety operations, handling program-level drug safety/PV activities. This role will work closely with the existing drug safety team and the head of regulatory affairs and drug safety to ensure all aspects of drug safety operational requirements for novel drug clinical development are managed.
Key Responsibilities:
- Works with external vendors on safety case processing and systems management
- Develops and implements drug safety/PV infrastructure and systems
- Oversees and manages Roivant's safety database system
- Oversees safety processes and SOPs
- Works with existing drug safety team at Roivant and at subsidiary Vants to ensure all drug safety responsibilities are appropriately handled
- Works closely with regulatory affairs at Roivant and/or at the subsidiary Vants to ensure all drug safety regulatory reporting requirements are met
- Responsible for developing and managing any pharmacovigilance agreements with external partners
- Assesses clinical study-specific safety, whether it is at the study design standpoint or at the level of a specific safety case report
- Handles in-licensing due diligence from a drug safety/PV standpoint
- Functions as the drug safety/pharmacovigilance subject matter expert on program and diligence teams
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 who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
About Roivant Sciences:
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.
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