Global Pharmacovigilance
2 weeks ago
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.
Global Pharmacovigilance (PV) Senior Scientist, Obesity - US Remote
Live
What you will do
Lets do this. Lets change the world. In this vital role the Global PV Senior Scientist will work within the Therapeutic Safety Teams and will be responsible for safety deliverables for assigned Amgen products throughout product life-cycles.
Key responsibilities:
Support and provide oversight with regards to safety in clinical trials by providing inputs on study protocols, statistical analysis plan, other study related documents and review of safety data from clinical studiesDirect the planning, preparation, writing and review of portions of aggregate reportsOrganize and direct liaison for activities with affiliates and other internal Amgen partners regarding productsSupports 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 systemAuthor Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSOSearch and review adverse event data, literature, and other safety-relevant data for the purpose of signal detectionPrepare presentation of the Global Safety Teams 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 responsibilityWinWhat we expect of you We are all different, yet we all use our unique contributions to serve patients. The Safety professional we seek is a collaborative partner with these qualifications. Basic Qualifications: Doctorate degree and 2 years of safety/ pharmacovigilance experience OR Masters degree and 4 years of safety/ pharmacovigilance experience OR Bachelors degree and 6 years of safety/ pharmacovigilance experience OR Associate degree and 10 safety/ pharmacovigilance experience OR High school diploma / GED and 12 years of safety/ pharmacovigilance experience Preferred Qualifications:Experience in Obesity therapeutic areaExperience in clinical studies with large number of participants and data setsThriveWhat you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $142,859.00 to $168, 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 comprising 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 including: 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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imagination Objects in your future are closer than they appear. Join us. 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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. 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.-
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