Global Safety Senior Scientist

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 missionto serve patients living with serious illnessesdrives 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. Global Safety Senior Scientist What you will do Let's do this. Let's change the world. In this vital role the Global PV Sr. Scientist works with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. This person will also provide scientific and compliance expertise as needed to GPS. The Global PV Sr. Scientist is responsible for the following: Applicable tasks may vary by product(s) assigned. Direct the planning, preparation, writing and review of portions of aggregate reports Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products Support and provide oversight to staff with regards to safety in clinical trials to: Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents Review of AEs/SAEs from clinical trials as needed Review standard design of tables, figures, and listings for safety data from clinical studies Participate in development of safety-related data collection forms for clinical studies Participate in study team meetings as requested or needed Signal detection, evaluation, and management- Perform data analysis to evaluate safety signals and write up analysis results Documents work as required in the safety information management system Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection Prepare presentation of the Global Safety Team's recommendations on safety issues to the cross-functional decision-making body Assist GSO in the development of risk management strategy and activities: Provides contents for risk management plans Develop or update strategy and content for regional risk management plans Assist GSOs to oversee risk minimization activities including tracking of activities as needed. Evaluate risk minimization activity Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO Support activities related to new drug applications and other regulatory filings: Assist GSO in developing a strategy for safety-related regulatory activities Provide safety contents for filings Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility Processes and regulations for pharmacovigilance and risk management Drug development and lifecycle management Safety data capture in clinical development and post-market settings Safety database structure and conventions MedDRA and other dictionaries used in pharmacovigilance Methods of qualitative and quantitative safety data analysis Product and disease state knowledge Risk management and risk minimization Inter-relationship across various pharmacovigilance processes and documents, including reference safety information and product labeling Advanced understanding of interfaces across various pharmacovigilance and risk management processes Internal organizational and governance structure Pharmacovigilance skills-intermediate knowledge of the following: Signal detection, evaluation and management Aggregate data analysis, interpretation and synthesis Good clinical and scientific judgment Application of medical concepts and terminology Document writing and source document review Writing Risk Management Plans Ability to convey complex, scientific data in an understandable way Ability to analyze and interpret complex safety data Intermediate skills in application of statistical and epidemiological methods to pharmacovigilance Biomedical Literature-intermediate skills: Literature Surveillance: source document review knowledge and skills Literature search, evaluation and assessment skills-ability to search literature databases to identify safety literature for signal evaluation and assessment, interpretation and synthesis skills What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek has these qualifications. Basic Qualifications: Doctorate degree and 2 years of safety experience Or Master's degree and 4 years of safety experience Or Bachelor's degree and 6 years of safety experience Or Associate's degree and 10 years of safety experience Or High school diploma / GED and 12 years of safety experience Preferred Qualifications: Broad PV knowledge with expertise within defined subject area Applies knowledge and broad understanding of multiple disciplines Understands impact of emerging scientific/technical trends and their implications for Amgen Problem solving: Analyzes and forecasts scientific/technical trends Develops solutions to problems through in-depth analysis, coordination and negotiation with key decision makers Performs complex work-flow analysis on processes impacting multiple areas across the organization Adapts and integrates own experience with Amgen-wide strategy Develops innovative solutions to problems without precedent Proposes new processes to achieve strategic business objectives Works in partnership with GPS team to develop business plans that support the direction of the business Autonomy: Guided by business plans and strategy Executes strategy, goals and changes within area of responsibility Contributes to strategic decisions affecting the discipline Guides ideas through development into a final product What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. 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. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include: 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, 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 Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. 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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. 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, disability status, or any other basis protected by applicable law. 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. . Salary Range 148,053.00 USD - 172,515.00 USD Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen