Observational Research Manager - Pharmacovigilance Epidemiology and Causal Inference
About the position Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas - Oncology, Inflammation, General Medicine, and Rare Disease - we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives. Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Responsibilities • Designs and implements models to estimate patient exposure to Amgen marketed products. • Designs and implements retrospective database studies in support of safety and pharmacovigilance. • Provides epidemiological input to worldwide regulatory submissions such as PSURs and RMPs. • Executes or leads research projects involving the analysis of multiple databases. • Provides safety research support across the life cycle of Amgen products. • Supports development of risk management plans. • Conducts literature reviews and prepares research reports and scientific manuscripts. • Stays abreast of the latest developments in the field of observational research and drug development. • Promotes awareness, understanding, and use of observational research methods. • Supports relationships with key leaders in observational research. • Provides input into observational research department meetings. • Communicates significant scientific information to a variety of audiences. Requirements • Doctorate degree. • Or Master's degree and 2 years of scientific experience. • Or Bachelor's Degree and 4 years of scientific experience. • Or Associate's degree and 8 years of scientific experience. • Or High school diploma / GED & 10 years of scientific experience. Nice-to-haves • Doctorate in Epidemiology or other subject with high observational research content. • Experience in the design, execution, and analysis of observational research studies within a pharmaceutical or public health setting. • Experience in observational research project planning and management. • Experience communicating observational research information, written and oral. • Experience working in multi-disciplinary teams. • Record of publications in observational research or clinical journals. Benefits • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions. • Group medical, dental and vision coverage. • Life and disability insurance. • Flexible spending accounts. • A discretionary annual bonus program. • Stock-based long-term incentives. • Award-winning time-off plans. • Flexible work models, including remote and hybrid work arrangements. Apply tot his job