DIRECTOR, PHARMACOVIGILANCE SCIENCE               

Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinical evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages. For more information, please visit our website at http://www.dayonebio.com.

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POSITION SUMMARY: 

The Associate Director, Pharmacovigilance (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 Day One Biopharmaceutical’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, Safety Operations and Compliance.

ESSENTIAL DUTIES AND 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 input 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 input for regulatory responses and submissions

 

QUALIFICATIONS

• Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in PV
• 4+ years’ pharmaceutical industry experience, including 2+ 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 preferable.
• Education and/or experience with basic statistics is an asset
• Experience in the preparation and authoring of pre- and post- aggregate safety reports
• Ability to execute and follow-through to completion and documentation
• Ability to work effectively in a collaborative team environment where results will be 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
• Strong computer skills desirable, particularly Power Point preparations.
• Excellent oral and written communication skills

The preceding job description has been designed to indicate the general nature and level of work performed by employees within classification. 

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DISCLAIMER

Day One Biopharmaceuticals is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Employment is conditioned upon full vaccination from the COVID-19 virus, including submission of documented proof thereof, as of the start date.  Day One Biopharmaceuticals will comply with applicable law regarding the reasonable accommodation of individuals who are not vaccinated because of a disability and/or sincerely held religious belief.

Recruitment & Staffing Agencies: Day One Biopharmaceuticals do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceutical’s internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.