The Director, PV Science will serve as a safety expert accountable for the global safety strategy and safety profile for the assigned product(s) throughout the product’s lifecycle. This role will provide strategic and operational Safety Science support for Arcus’s developmental products in close collaboration with other Safety and Medical staff. This individual must be able to work effectively in a matrix, with multiple other departments across the organization, and with external stakeholders such as Investigators and Regulatory Agencies. This position will report to the Senior Director, PV Science.
Responsibilities
- Oversight of day-to-day safety monitoring activities and safety data for the assigned product
- Review and synthesis of individual case reports as well as aggregate data summaries
- Provide safety science and pharmacovigilance subject matter expertise on program and study teams as well as other cross-functional platforms throughout the company
- Facilitate cross-functional Safety Review Committee meetings; includes coordinating materials, data presentation and all outputs, and agenda
- Review and provide PV input to all core clinical documents including protocols, IBs, ICFs, and CSRs
- Authoring of aggregate safety reports, e.g., DSURs, PSURs
- Provide subject matter expertise and input for regulatory responses and submissions
- Assist the Sr. Director, PV Science in building core PV capabilities and processes for the department
Qualifications
- Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in PV
- 8+ years’ pharmaceutical industry experience, including 5+ years’ experience in PV
- Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data; oncology experience is preferred
- Experience in the preparation and authoring of pre- and post- aggregate safety reports
- Thorough understanding of the drug development process and context applicable to safety surveillance activities
- Ability to execute and follow-through to completion and documentation
- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
- Independently motivated, detail oriented and good problem-solving ability
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
- Excellent oral and written communication skills
- Ability to work and influence cross-functionally
- Solid foundation in GCP and GVP regulations
This role can be based at our Hayward or Brisbane, CA locations (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $213,000 – $250,000. For remote-based candidates, the salary range may vary based on local market data. Factors such as relevant experience, education, duration of experience, and length of industry experience will influence the actual salary offered. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers/.
Arcus is an EEO.
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