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Global Pharmacovigilance (PV) Scientist, Manager- Oncology

AmgenUnited States - RemoteremoteSalary not postedView the original posting at Amgen ↗

Career Category Safety Job Description 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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. Global Pharmacovigilance Manager What you will do Let’s do this. Let’s change the world. In this vital role, you will partner closely with Global Safety Officers (GSOs), Clinical Development, Regulatory Affairs, and other cross-functional stakeholders to develop and execute product safety strategies across the product lifecycle, from early development through post-marketing phases. The Immuno-Oncology team supports an exciting portfolio spanning investigational and marketed products, requiring innovative and collaborative safety leadership to ensure patients have access to safe and effective therapies. The Global Pharmacovigilance Manager is responsible for the following: Product Safety Surveillance & Signal Management Lead signal detection, validation, prioritization, evaluation, and management activities utilizing multiple safety data sources and signal detection methodologies. Conduct scientific and medical evaluation of adverse events and emerging safety concerns from clinical trials, post-marketing surveillance, literature, and external data sources. Perform complex safety analyses and communicate evidence-based recommendations supporting product safety decisions. Integrate information from safety databases, clinical studies, literature, epidemiology, and external sources to assess potential safety signals. Support and contribute to benefit-risk evaluations that inform product development, regulatory submissions, labeling updates, and lifecycle management decisions. Collaborate with GSOs to evaluate safety concerns and recommend appropriate risk mitigation strategies. Aggregate Safety Reporting & Safety Assessments Lead or contribute to the planning, preparation, authoring, review, and submission of aggregate safety reports, including: PBRERs/PSURs DSURs Safety Assessment Reports Regulatory safety responses Other global pharmacovigilance deliverables Prepare clear, scientifically sound analyses and conclusions regarding product safety profiles. Ensure the quality, consistency, and scientific integrity of safety assessments and aggregate reports. Clinical Development Support Provide strategic safety input into clinical protocols, statistical analysis plans, safety analysis plans, investigator brochures, and clinical study reports. Review and provide recommendations regarding safety data presentations, including tables, figures, and listings. Participate on study teams and collaborate with Clinical Development partners to support ongoing safety surveillance activities. Contribute to development of safety-related data collection tools and methodologies for clinical studies. Safety Governance & Cross-Functional Leadership Represent Global Patient Safety within safety governance and cross-functional teams. Present safety analyses, emerging signals, benefit-risk assessments, and Global Safety Team re

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