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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.Medical Review Senior Medical ScientistLiveWhat you will doLet’s do this. Let’s change the world. In this vital role you will provide medical review of individual case safety reports (ICSRs) in support of safety surveillance for Amgen products. To support global individual case safety reports regulatory reporting compliance.Responsibilities:
Assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT)
Implement the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports
You will be the point of contact between Case Management and GSOs on medical content and regulatory reporting of ICSRs
Act as MSRT process lead and support the development, training on and implementation of new processes in MSRT (if applicable)
Support training to Amgen employees on ICSR medical review
Mentor junior medical reviewers. As needed and applicable, provide direct managerial responsibilities for medical reviewers on their therapeutic or functional team
WinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a key contributor with these qualifications.Basic Qualifications:Doctorate degree and 2 years experienceOrMaster’s degree and 6 years experienceOrBachelor’s degree and 8 years experienceOrAssociate’s degree and 10 years experienceOrHigh school diploma / GED and 12 years of experiencePreferred Qualifications:
MD/DO or international equivalent plus 3 years relevant work
Knowledge of Amgen case management and medical review SOPs and regulatory requirements for Pharmacovigilance
Clinical knowledge of therapeutic area patient populations and drug class
Proficiency in technical safety systems including the Amgen Safety database and medical coding
Knowledge of safety data capture in clinical trials and in the post marketing environments
Knowledge of clinical trials and drug development
Knowledge of Amgen products and patient population
ThriveWhat you can expect of usAs 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.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:
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.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAmgen 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.
