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    Global Pharmacovigilance (Pv) Senior Scientist, Obesity, Us - Remote

    Amgen
    2+ years
    142,859.00 USD - 168,300.00 USD
    Remote, USA
    10 Nov. 18, 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, CPC Certified, 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: Global Pharmacovigilance (PV) Senior Scientist, Obesity – US Remote

    Location: US Remote

    Duration: Full-Time

    Description:

    At Amgen, our mission to serve patients drives everything we do. As one of the world’s leading biotechnology companies, we are seeking a highly skilled and motivated Global PV Senior Scientist to join our team. This role will focus on safety deliverables for Amgen products throughout their lifecycle, specifically within the therapeutic area of obesity. The position is remote, allowing flexibility, while also offering opportunities to collaborate across global teams.

    Key Responsibilities:

    • Provide oversight and safety support in clinical trials, including inputs on study protocols, statistical analysis plans, and review of safety data.
    • Lead the planning, preparation, and review of aggregate reports and safety-related documents.
    • Collaborate with internal Amgen teams and affiliates to ensure comprehensive safety assessments.
    • Contribute to signal detection, evaluation, and management, including data analysis and safety report creation.
    • Assist in the development of risk management strategies, including preparation of risk management plans and regulatory filings.
    • Support the development and tracking of risk minimization activities and regulatory responses under the guidance of Global Safety Operations (GSO).
    • Represent Amgen in Health Authority Inspections and internal audits, ensuring inspection readiness.

    Qualifications:

    Basic Requirements:

    • Doctorate with 2 years of pharmacovigilance experience, or
    • Master's degree with 4 years of pharmacovigilance experience, or
    • Bachelor's degree with 6 years of pharmacovigilance experience, or
    • Associate degree with 10 years of pharmacovigilance experience, or
    • High school diploma/GED with 12 years of pharmacovigilance experience.

    Preferred Qualifications:

    • Experience in obesity therapeutic area.
    • Experience in large-scale clinical studies and handling large data sets.

    What We Offer:

    • Competitive salary range: $142,859 to $168,300.
    • Comprehensive benefits package, including health, dental, vision, life insurance, and retirement plans.
    • Generous paid time off and bi-annual company-wide shutdowns.
    • Flexible work models, including remote work arrangements where applicable.

    Amgen is an Equal Opportunity employer and values diversity. We offer reasonable accommodations for individuals with disabilities to participate in the job application or interview process.

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