Director of Pharmacovigilance Systems and Operations (Remote)

Roivant; New York (NY); Remote; USD 120,000 - 180,000; Full time

Job summary

An established industry player is seeking a Director of Pharmacovigilance Systems and Operations to lead its safety management infrastructure. This role involves developing strategic safety systems and ensuring compliance with regulatory requirements in a fast-paced environment. The ideal candidate will have extensive experience in drug development, particularly in managing safety systems and vendor relationships. Join a dynamic team that values innovation and collaboration, where your expertise will play a crucial role in advancing drug safety operations and improving patient outcomes.

Qualifications

• 15+ years of drug development experience in the pharmaceutical industry.
• Proven experience with safety systems and project management.

Responsibilities

• Lead Roivant’s drug safety infrastructure and safety database systems.
• Oversee safety/PV processes and ensure regulatory compliance.
• Manage pharmacovigilance agreements with external partners.

Skills

Drug Development

Project Management

Pharmacovigilance Processes

Regulatory Affairs

Vendor Management

Communication Skills

Collaboration

Problem Solving

Tools

Aris Global

Veeva Vault

Job description

Director of Pharmacovigilance Systems and Operations (Remote)

Roivant Sciences, Inc., 151 West 42nd Street, 15th Floor, New York, NY 10036, United States

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 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.

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 ensure 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 support Roivant’s drug safety operations and 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 ensure seamless drug safety operations, and demonstrates clear leadership in developing and managing safety systems.

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 ensure all drug safety/PV 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 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/PV subject matter expert on program and diligence teams.
• Keeps up to date on the changing global regulatory landscape as it applies to drug safety and pharmacovigilance.

Skills, Qualifications and Requirements:

• 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.