**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. **Global Pharmacovigilance (PV) Senior Scientist** **What you will do** Let’s do this. Let’s change the world. The Global Safety Therapeutic Area Teams serve as the safety experts for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product. Amgen is seeking a Global Pharmacovigilance (PV) Senior Scientist to work out of their Thousand Oaks, CA facility. 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 Global Patient Safety, in the establishment of a highly effective global safety organization in full compliance to worldwide regulations. **The Senior Scientist is responsible for the following:** + Directs the planning, preparation, writing and review of portions of aggregate reports + Organizes and directs liaison activities with affiliates and other internal Amgen partners regarding product safety + Supports and provides oversight to staff with regards to safety in clinical trials + Reviews and provides input and support on study protocols, statistical analysis plans and other clinical study- related documents + Reviews Adverse Event/Serious Adverse Event (AEs/SAEs) from clinical trials + Reviews and provides input on 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 + Participates in study team meetings + Performs data analysis to evaluate safety signals and writes up analysis results for signal detection, evaluation and management + Authors Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the Global Safety Officer (GSO) + Prepares presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body + Provides content for risk management plans + Develops or updates strategy and content for regional risk management plans + Assist GSOs to oversee risk minimization including tracking of activities and developing a strategy for safety-related regulatory activities + Prepares response to regulatory inquiries related to risk management plans under the guidance of GSO + 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 a representative and a point of contact for Health Authority Inspections and Internal Process Audits within the remit of role and responsibility **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 Scientific clinical experience or current Pharmacovigilance or Drug Safety experience or Biotech/Pharmaceutical experience Or Master’s degree and 4 years of Scientific clinical experience or current Pharmacovigilance or Drug Safety or Biotech/Pharmaceutical experience Or Bachelor’s degree and 6 years of Scientific clinical experience or current Pharmacovigilance or Drug Safety or Biotech/Pharmaceutical experience Or Associate’s degree and 10 years of Scientific clinical experience or current Pharmacovigilance or Drug Safety or Biotech/Pharmaceutical experience Or High school diploma / GED and 12 years of Scientific clinical experience or current Pharmacovigilance or Drug Safety or Biotech/Pharmaceutical experience **Preferred Qualifications:** + BS, RN or PharmD degree + 8+ years of Pharmacovigilance in a Pharmaceutical or Biotech industry + Broad PV knowledge with expertise within defined subject area. + Applied knowledge and broad understanding of multiple disciplines + Experience in signal detection, evaluation, aggregate data analysis, and interpretation + Experience with document writing and source document review + Ability to convey complex, scientific data in an understandable way + Good clinical and scientific judgment + Knowledge of Application of medical concepts and terminology + Literature search, evaluation and assessment skills-ability to search literature databases to identify safety literature for signal evaluation and assessment, interpretation and synthesis skills + Collaboration with cross-functional team settings + Meeting management and time management skills + Process and project management skills + Critical scientific assessment and problem solving + Strong Written and verbal communications skills, including medical/scientific writing + Computer skills (e.g., MS Office Suite and safety systems) + Presentation skills for conveying complex technical contents to non-expert audiences **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** **for a career that defies imagination** Objects in your future are closer than they appear. Join us. **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.