Amgen

Global Safety Physician (GSP), Senior Medical Scientist. In this vital role you will serve as the medical expert for the team to support the Global Safety Officer in the management of safety signal, risk management activities, and benefit risk assessments for an assigned set of products.. The Global Safety Physician will report to either a Global Safety Officer (GSO) or the Executive Medical Director Global Patient Safety and will be responsible for the conduct of safety monitoring and accountable for delivering product related safety decisions and deliverables for assigned products as designated by the GSO or TAH (Therapeutic Area Head).. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.. Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO and Pharmacovigilance scientist

medical scientist

HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. 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. It’s time for a career you can be proud of. Global Safety Physician (GSP), Senior Medical Scientist Live What You Will Do Let’s do this. Let’s change the world. In this vital role you will serve as the medical expert for the team to support the Global Safety Officer in the management of safety signal, risk management activities, and benefit risk assessments for an assigned set of products. The Global Safety Physician will report to either a Global Safety Officer (GSO) or the Executive Medical Director Global Patient Safety and will be responsible for the conduct of safety monitoring and accountable for delivering product related safety decisions and deliverables for assigned products as designated by the GSO or TAH (Therapeutic Area Head). The Global Safety Officer may delegate to the Global Safety Physician. The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product from early clinical development to marketed products. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations. <ul><li>Directs the planning, preparation, writing and review of portions of aggregate reports</li><li>Organize and direct liaison activities with affiliates and other internal Amgen partners regarding products</li><li>Supports and provides oversight with regards to safety in clinical trials to</li><li>Review and provide input on study protocols, statistical analysis plans, provide safety contents for regulatory filings. Reviews safety tables, figures, and listings from clinical studies.</li><li>Support activities related to new drug applications and other regulatory filings</li><li>Perform Signal detection, evaluation, and management</li><li>Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO and Pharmacovigilance scientist</li><li>Prepare presentations to the Global Safety Team on safety issues</li><li>Assist GSO in the development of risk management strategy and activities, and safety-related regulatory activities</li><li>Additional duties as assigned </li></ul>Win What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Basic Qualifications: MD or DO degree from an accredited medical school Preferred Qualifications: <ul><li>One year experience in product safety in the bio/pharmaceutical industry</li><li>Clinical experience in either an accredited academic setting or private practice (including hospital based) setting</li><li>Clinical/medical research experience</li><li>2 years product safety experience in the bio/pharmaceutical industry</li><li>Experience in Oncology </li></ul>Thrive What You Can Expect Of Us As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: <ul><li>Comprehensive employee 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.</li><li>A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan</li><li>Stock-based long-term incentives</li><li>Award-winning time-off plans and bi-annual company-wide shutdowns</li><li>Flexible work models, including remote work arrangements, where possible </li></ul>Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided 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 accommodation.

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