Senior Director - PV Science, Patient Safety & Pharmacovigilance
Description
Summary
The Senior Director, PV Science will serve as the manager of Safety Science team within the Patient Safety & Pharmacovigilance Department and a safety expert accountable for the global safety strategy and safety profile for assigned product(s) throughout the product’s lifecycle. This role will provide strategic and operational PV 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, Regulatory Agencies, and safety vendors. This position will report to the Head of Safety.
Responsibilities
- Manage a team of PV scientists
- Interact with cross-functional leaders for establishing process improvement as necessary
- Provide guidance to the PV Science team on the day-to-day safety monitoring activities and safety data for assigned products
- Review and summarize individual case reports as well as aggregate data summaries as needed
- 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 Science 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
- Work with the Medical Safety team in building core PV science 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
- 15+ years’ experience in pharmaceutical industry, including 10+ years’ experience in PV
- Track record of strong personal performance combined with demonstrated ability to lead a high performing team
- Experience with working with safety vendors managing deliverables to support PV Science projects
- 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
Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.
Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
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