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    Global Safety Officer - United Kingdom - Amgen Inc. (IR)

    Amgen Inc. (IR)
    Amgen Inc. (IR) United Kingdom

    1 week ago

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    Description
    Global Safety Officer (GSO), Global Safety Medical Director, Oncology page is loaded Global Safety Officer (GSO), Global Safety Medical Director, Oncology
    Apply remote type Remote locations United Kingdom - Cambridge United Kingdom - Manchester United Kingdom - Southampton United Kingdom - London United Kingdom - Birmingham time type Full time posted on Posted 22 Days Ago job requisition id R Career Category
    Safety Job Description
    It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Global Safety Officer (GSO), Global Safety Medical Director, Oncology, UK - Remote

    In this vital role you will establish the strategy, direction, and priorities of pharmacovigilance activities and are accountable for the overall safety profile and all product-related decisions and deliverables for assigned products.

    You will also lead the Safety Analysis Team (SAT), Global Safety Team (GST) and are a core member of the Executive Safety Committee (ESC).

    Validate safety signals and lead safety signal assessments
    Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.)
    Prepare/review core and regional risk management plans including additional risk minimization measures
    Prepare/review safety sections of periodic aggregate reports
    Provide safety input to protocols, statistical analysis plans, and clinical study reports
    Prepare/review safety sections of new drug applications and other regulatory filings
    Serve as safety expert on Evidence Generation Team for assigned products
    Domestic and International travel up to 10%
    The Medical Safety professional we seek is a leader with these qualifications.
    MD or DO degree from an accredited medical school
    Completion of an accredited medical or surgical residency or clinical experience in either an accredited academic setting or private practice (including hospital based) setting
    Product safety experience either in the bio/pharmaceutical industry or in regulatory agency.
    Expertise in Oncology therapeutic area, or clinical training.
    Experience with marketed product safety; risk management.
    Leadership experience of the safety profile of products assigned with cross-functional team members.

    As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.

    Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent
    Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
    Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

    Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

    We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

    Please contact us to request an accommodation.
    . Global Safety Officer (GSO), Global Safety Medical Director

    locations 6 Locations time type Full time posted on Posted 30+ Days Ago Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.

    Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.

    A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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