Director of Pharmacovigilance Systems and Operations
| Company | Roivant Sciences |
|---|---|
| Location | New York, NY, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Master’s, MD |
| Experience Level | Expert or higher |
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 have experience in global phase 1 early stage programs through phase 3 late stage programs
- Must have experience in global clinical studies and reporting requirements
- Strong understanding of PV processes and quality requirements
- 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
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
Preferred Qualifications
- Experience with ArisGlobal LSMV and Veeva Vault systems is strongly preferred
- Must be a pro-active, self-motivated, goal oriented individual with demonstrated strong project management skills
- Willing to learn, expand knowledge and role as needed, understanding that there will always be something new to learn, do and develop
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders, including external vendors, contractors and strategic partners
- Must be a decisive individual with the flexibility and creativity to excel in and contribute to a rapidly growing company