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Global Safety Sr Mgr (US - Remote)

Company: Amgen
Location: Houston
Posted on: January 16, 2022

Job Description:

Career CategoryMedical AffairsJob DescriptionHOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.Global Safety Senior ManagerLiveWhat 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. This person will also provide scientific and compliance expertise to Global Patient Safety (GPS).Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection.Perform data analysis to evaluate safety signals and write up analysis results.Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the Global Safety Officer (GSO).Direct the planning, preparation, writing and review of safety portions of aggregate reports.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: Provide 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; 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.Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products.Provide support for clinical trials to review and provide input to study-related documents (e.g., study protocols; statistical analysis plans; safety-related data collection forms; and design of tables, figures, and listings for safety data from clinical studies) and provide aggregate review of Adverse Events (AEs)/Serious Adverse Events (SAEs) from clinical trials.Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the Pharmacovigilance (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.WinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is a partner with these qualifications.Basic QualificationsDoctorate degree and 2 years of directly related experience ORMaster's degree and 6 years directly related experience ORBachelor's degree and 8 years of directly related experiencePreferred QualificationsRN, PharmD, MPH or PAThree to five years direct experience in pharmacovigilance: signal detection and evaluation; data analysis interpretation and synthesis; periodic report productionKnowledge of processes and regulations for pharmacovigilance and risk managementClinical/medical research experienceThriveWhat you can expect of usAs we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.Vast opportunities to learn and move up and across our global organizationDiverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefitsApply nowfor a career that defies imaginationIn our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.careers.amgen.comEqual Opportunity StatementAmgen 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 a 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 an accommodation..Full time

Keywords: Amgen, Houston , Global Safety Sr Mgr (US - Remote), Other , Houston, Texas

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