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Associate Director, Pv Scientist

3+ years
Not Disclosed
10 July 29, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Associate Director, PV Science

Description:
The Associate Director, PV Science, will serve as a safety expert responsible for developing and monitoring the safety profile of assigned products throughout their lifecycle. This role involves providing Safety Science support for Arcus’s developmental products, working closely with other Safety and Medical staff, and collaborating with multiple departments within the organization, as well as with external stakeholders like Investigators and Regulatory Agencies.

Contract Details:

  • Duration: 6 months
  • Hours: 40 hours per week

Responsibilities:

  • Oversee daily safety monitoring activities and safety data for assigned products.
  • Review and synthesize individual case reports and aggregate data summaries.
  • Provide safety science and pharmacovigilance expertise on program and study teams and other cross-functional platforms.
  • Facilitate Safety Review Committee meetings, including coordinating materials, data presentation, outputs, and agenda.
  • Review and provide PV input on core clinical documents such as protocols, IBs, ICFs, and CSRs.
  • Author aggregate safety reports, including DSURs and PSURs.
  • Provide subject matter expertise and input for regulatory responses and submissions.

Qualifications:

  • Degree in Pharmacy, Nursing, Epidemiology, Biosciences, or an equivalent healthcare degree with a pharmaceutical industry background and proven competence in PV.
  • 4+ years of pharmaceutical industry experience, including 3+ years in PV.
  • Experience reviewing cumulative safety data, with the ability to interpret, synthesize, and communicate complex clinical/pharmaceutical information and safety data; oncology experience preferred.
  • Experience in the preparation and authoring of pre- and post-market aggregate safety reports.
  • Thorough understanding of the drug development process and safety surveillance activities.
  • Ability to execute and follow through to completion and documentation.
  • Effective collaboration skills in a team environment, achieving results through influence and incorporating multiple viewpoints.
  • Independent motivation, attention to detail, and problem-solving skills.
  • Excellent organizational skills, with the capacity to multitask in a fast-paced environment with changing priorities.
  • Strong oral and written communication skills.
  • Ability to work and influence cross-functionally.
  • Solid foundation in GCP and GVP regulations.

Equal Opportunity Employment:
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 identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other legally protected status. EOE/AA/Vets