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    Global Safety Manager

    Amgen
    2-8 years
    116,086.00 USD - 138,564.00 USD
    Remote, USA
    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 Description

    HOW MIGHT YOU DEFY IMAGINATION?

    You've worked hard to become the professional you are today and are now ready to take the next step in your career. At Amgen, our shared mission—to serve patients—drives everything we do. As one of the world’s leading biotechnology companies, we reach over 10 million patients worldwide. Join us in this meaningful role and do your best work alongside other innovative, driven professionals.

    Global Safety Manager

    Live

    What you will do

    Let’s do this. Let’s change the world. In this vital role, you will work with the Therapeutic Safety Teams on safety assessment activities for medical/scientific operations. The Global Safety Manager will also provide scientific and compliance expertise to Global Patient Safety (GSP).

    Responsibilities:

    • Contribute to the planning, preparation, writing, and review of portions of aggregate reports.
    • Collaborate with affiliates and other internal Amgen partners regarding deliverables.
    • Review adverse events (AEs) and serious adverse events (SAEs) from clinical trials as needed.
    • Provide input and support for study protocols, statistical analysis plans, and other clinical study-related documents.
    • Review standard designs of tables, figures, and listings for safety data from clinical studies.
    • Participate in the development of safety-related data collection forms for clinical studies.
    • Attend study team meetings as requested or needed.
    • Perform data analysis for signal detection, evaluation, and management; document work in the safety information management system.
    • Author Safety Assessment Reports and other safety documents; collaborate with the GSO for regulatory responses.
    • Search and review adverse event data, literature, and other safety-relevant data for signal detection.
    • Present the Global Safety Team’s safety issue recommendations to the cross-functional decision-making body.
    • Assist GSO in developing risk management strategies and activities, including risk management plans and regulatory responses.
    • Support activities related to new drug applications and other regulatory filings.
    • Ensure inspection readiness, including representing the team during Health Authority Inspections and Internal Process Audits.
    • Understand processes and regulations for pharmacovigilance, safety data capture, safety database structure, and conventions.
    • Apply qualitative and quantitative safety data analysis methods.

    Pharmacovigilance Skills:

    • Intermediate knowledge of signal detection, evaluation, and management.
    • Skills in aggregate data analysis, interpretation, and synthesis.
    • Application of medical concepts and terminology.
    • Proficiency in writing Risk Management Plans and document review.
    • Ability to communicate complex scientific data understandably and analyze safety data.

    Biomedical Literature Skills:

    • Literature surveillance, including source document review and skills in literature search, evaluation, assessment, interpretation, and synthesis.

    Win

    What we expect of you

    We value diversity and unique contributions that serve our patients. The professional we seek has these qualifications:

    Basic Qualifications:

    • Doctorate degree, or
    • Master’s degree with 2 years of Clinical and/or Drug Safety experience, or
    • Bachelor’s degree with 4 years of Clinical and/or Drug Safety experience, or
    • Associate’s degree with 8 years of Clinical and/or Drug Safety experience, or
    • High school diploma / GED with 10 years of Clinical and/or Drug Safety experience.

    Preferred Qualifications:

    • Medical qualification (BSN, PharmD, DDS/DMD, PA, or international equivalent).
    • Knowledge of Amgen Case Management and medical review SOPs.
    • Clinical knowledge of therapeutic areas and patient populations.
    • Proficiency in technical safety systems, including Safety Database and medical coding.
    • Understanding of clinical trials, drug development, and Amgen products.
    • Commitment to training and developing junior staff.

    Thrive

    What you can expect from us

    We support our team’s professional and personal growth and well-being. Amgen offers a comprehensive benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts. We also offer a discretionary annual bonus program, stock-based long-term incentives, award-winning time-off plans, and flexible work models, including remote work arrangements where possible.

    Salary Range: $116,086.00 - $138,564.00

    Apply now for a career that defies imagination.

    Objects in your future are closer than they appear. Join us at careers.amgen.com.

    Application Deadline:

    Amgen does not have a fixed application deadline for this position; applications will be accepted until we find the right candidate.

    Amgen is an Equal Opportunity Employer and considers applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We ensure reasonable accommodation for individuals with disabilities during the job application or interview process and for performing essential job functions. Please contact us to request accommodation.

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