Global Pharmacovigilance (PV) Senior Scientist

Career CategorySafetyJob DescriptionJoin Amgen’s Mission of Serving PatientsAt 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 (PV) Senior Scientist What you will doLet’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 reportsOrganize and direct liaison for activities with affiliates and other internal Amgen partners regarding productsAuthor Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSOSupports 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 documentsReview of AEs/SAEs from clinical trials as neededReview standard design of tables, figures, and listings for safety data from clinical studiesParticipate in development of safety-related data collection forms for clinical studiesParticipate in study team meetings as requested or neededSignal detection, evaluation, and management- Perform data analysis to evaluate safety signals and write up analysis resultsDocuments work as required in the safety information management systemSearch and review adverse event data, literature, and other safety-relevant data for the purpose of signal detectionPrepare presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making bodyAssist GSO in the development of risk management strategy and activities:Provides contents for risk management plansDevelop or update strategy and content for regional risk management plansAssist GSOs to oversee risk minimization activities including tracking of activities as needed.Evaluate risk minimization activityPrepare response to regulatory inquiries related to risk management plans under the guidance of GSOSupport activities related to new drug applications and other regulatory filingsAssist GSO in developing a strategy for safety-related regulatory activitiesProvide safety contents for filingsInspection ReadinessUndertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readinessBe representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibilityWhat we expect of youWe 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 experienceORMaster’s degree and 4 years of related experienceORBachelor’s degree and 6 years of related experienceORAssociate’s degree and 10 years of related experienceORHigh school diploma / GED and 12 years of related experiencePreferred Qualifications:BS or BA in Life Science with a MS and 6 years of related experienceBachelor’s degree and 8 years of related experience2 years of managerial experience directly managing people and or leadership experience leading teams, project, programs or directing the allocation of resourcesClinical/medical research experience6 years of experience in a biotech/pharmaceutical settingPrevious management and/or mentoring experienceWhat you can expect of usAs 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 accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn 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 deadlineAmgen 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.SponsorshipSponsorship for this role is not guaranteed.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 Range140,799.10USD -190,492.90 USDSummaryLocation: United States - Remote; US - Wyoming - Cheyenne; US - Texas - Houston; US - Kentucky - Louisville; US - Georgia - Atlanta; US - Kansas - Wichita; US - Mississippi - Jackson; US - Wisconsin - Milwaukee; US - Ohio - Columbus; US - Minnesota - Minneapolis; US - North Dakota - Fargo; US - Iowa - Des Moines; US - West Virginia - Charleston; US - Washington D.C.; US - Washington - Seattle; US - Tennessee - Memphis; US - Indiana - Indianapolis; US - North Carolina - Charlotte; US - Florida - Jacksonville; US - South Dakota - Sioux Falls; US - Virginia - Virginia Beach; US - New York - New York; US - South Carolina - Columbia; US - Rhode Island - Providence; US - Michigan - Detroit; US - Arkansas - Little Rock; US - Delaware - Wilmington; US - New Mexico - Albuquerque; US - Vermont - Burlington; US - Pennsylvania - Philadelphia; US - Utah - Salt Lake City; US - New Jersey - Newark; US - Arizona - Phoenix; US - Oregon - Portland; US - Connecticut - Bridgeport; US - Alaska - Anchorage; US - Illinois - Chicago; US - New Hampshire - Manchester; US - Oklahoma - Oklahoma City; US - Colorado - Denver; US - Nevada - Las Vegas; US - Alabama - Birmingham; US - Massachusetts - Boston; US - Nebraska - Omaha; US - Montana - Billings; US - Maryland - Baltimore; US - Idaho - Boise City; US - Maine - Portland; US - Louisiana - New Orleans; US - Missouri - Kansas CityType: Full time