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    Global Safety Manager

    Hire Talent
    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

    Global Safety Manager - Clinical/Pharma Experience Required - Remote US

    Job Description

    ATTENTION MILITARY-AFFILIATED JOB SEEKERS - Our organization partners with companies to find qualified talent for open roles. This position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you meet the required skill set, education requirements, and experience, please click the submit button and follow the next steps.

    Location: Remote (Continental US, Alaska, Hawaii)

    In this vital role, you will collaborate with Therapeutic Safety Teams on safety assessment activities for medical and 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.
    • 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.
    • Skills in literature search, evaluation, assessment, interpretation, and synthesis.

    Auto req ID: 421270BR

    Minimum Education Required:

    • High School/GED

    Additional Qualifications/Responsibilities:

    • 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 safety data capture in Clinical Trials and Post Marketing settings.
    • Familiarity with clinical trials, drug development, and Amgen products.

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

    Location: United States

    Affiliate Sponsor: Amgen

    Country: United States

    Job Category: Pharmaceutical

    City/State: N/A

    Job Code: Pharmaceutical

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