Pharmacovigilance Scientist

Global Pharmacovigilance (PV) Senior Scientist 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 Direct the planning, preparation, writing and review of portions of aggregate reports Organize and direct liaison for activities with affiliates and other internal Amgen partners regarding products Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO 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 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 related experience Master’s degree and 4 years of related experience Bachelor’s degree and 6 years of related experience Associate’s degree and 10 years of related experience High school diploma / GED and 12 years of related experience Preferred Qualifications BS or BA in Life Science with a MS and 6 years of related experience Bachelor’s degree and 8 years of related experience 2 years of managerial experience directly managing people and/or leadership experience leading teams, project, programs or directing the allocation of resources Clinical/medical research experience 6 years of experience in a biotech/pharmaceutical setting Previous management and/or mentoring experience What you can expect of us 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 possible. Refer to the Work Location Type in the job posting to see if this applies. Equal Opportunity 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. #J-18808-Ljbffr