Amgen Global Safety Physician, Senior Medical Scientist, US-Remote in Thousand Oaks, California

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, Senior Medical Scientist US – Remote Live What you will do Let’s do this. Let’s change the world. In this vital role within the Global Patient Safety (GPS) organization, you will provide your medical expertise to the team to support the Global Safety Officer (GSO) in the conduct of safety assessments and risk management processes and activities for an assigned set of products through the product’s life cycle. The Global Safety Physician is responsible for the conduct of safety monitoring and accountable for delivering activities supporting product-related safety decisions and assigned products. The Global Safety Physician is responsible for the following: • Signal detection, evaluation, and management – performs data analysis to evaluate safety signals and authors analysis results for Safety Assessment Reports in collaboration with the GSO • Supports and reviews safety data in clinical trials, study protocols, statistical analysis plans and other clinical study-related documents; review of AEs/SAEs from clinical trials as needed; reviews standard design of tables, figures, and listings for safety data from clinical studies; participates in development of safety-related data collection forms for clinical studies and participates in study team meetings as requested or needed • Directs the planning, preparation, writing and review of portions of aggregate reports • Organizes and directs liaison activities with affiliates and other internal Amgen partner regarding products • Authors various safety documents and health authority responses in collaboration with the GSO • Searches and reviews adverse event data, literature, and other safety-relevant data for the purpose of signal detection • Prepares and presents Global Patient Safety’s recommendations on safety issues to the cross-functional decision-making body • Assists GSO in the development of risk management strategy and activities • Supports activities related to new drug applications and other regulatory findings • Inspection readiness – undertakes activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness • Be the representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The medical professional we seek is a leader with these qualifications. Basic Qualifications: • MD or DO degree from an accredited medical school Preferred Qualifications: • 2 years Clinical/medical research experience • Completion of an accredited medical or surgical residency • Clinical experience in either an accredited academic setting or private practice (including hospital based) setting • Product safety or clinical development in the bio/pharmaceutical industry • Previous management and or mentoring experience • Experience in leading teams and or projects 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 annual base salary range for this opportunity in the U.S. is $218,346. to $ 248,488. In addition to the base salary, 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 now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com Join Us If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancers, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to 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. Apply tot his job