Global Pharmacovigilance (PV) Scientist, Senior Manager

Career Category Safety Job Description 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 Senior Manager What you will do Let’s do this. Let’s change the world. In this vital role you will work with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. Responsibilities: Directs 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 Supports and provides 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 What we expect of you We are all different, yet we all use our unique contributions to serve patients. The pharmacovigilance professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree and 2 years of industry pharmacovigilance experience OR Master’s degree and 4 years of industry pharmacovigilance experience OR Bachelor's degree and 6 years of industry pharmacovigilance experience OR Associate’s degree and 10 years of industry pharmacovigilance experience OR High school diploma/GED and 12 years of industry pharmacovigilance experience Preferred Qualifications: BS in Life Science with 3 years drug safety experience, preferably industry pharmacovigilance experience Experience in Signal detection, evaluation and management Experience of Literature Surveillance: source document review knowledge and skills Experience in aggregate data analysis, interpretation and synthesis Good clinical and scientific judgment Clinical and/or medical research experience Understanding of methods of qualitative and quantitative safety data analysis 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 where po