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Global Safety Manager
3 months ago
HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Global Safety ManagerLive
What you will do
Lets do this. Lets change the world. In this vital role you will work with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. The Global Safety Manager will also provide scientific and compliance expertise as needed to Global Patient Safety (GSP).Responsibilities:
Contributes to the planning, preparation, writing and review of portions of aggregate reportsWorks with affiliates and other internal Amgen partners regarding deliverablesReview of AE/SAEs from clinical trials as neededReview 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 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 with aspects of 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 Readiness:Undertake 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 responsibilityProcesses and regulations for pharmacovigilance and risk managementDrug development and lifecycle managementSafety data capture in clinical development and post-market settingsSafety database structure and conventionsMedDRA and other dictionaries used in pharmacovigilanceMethods of qualitative and quantitative safety data analysisInter-relationship across various pharmacovigilance processes and documents, including reference safety information and product labelingPharmacovigilance skills-intermediate knowledge of the following:Signal detection, evaluation and managementAggregate data analysis, interpretation and synthesisApplication of medical concepts and terminologyDocument writing and source document reviewWriting Risk Management PlansAbility to convey complex, scientific data in an understandable wayAbility to analyze and interpret complex safety dataIntermediate skills in application of statistical and epidemiological methods to pharmacovigilanceBiomedical Literature-intermediate skills:Literature Surveillance: source document review knowledge and skillsLiterature search, evaluation and assessment skills-ability to search literature databases to identify safety literature for signal evaluation and assessment, interpretation and synthesis skillsWinWhat we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek has these qualifications. Basic Qualifications: Doctorate degree Or Masters degree and 2 years of Clinical and/or Drug Safety experience Or Bachelors degree and 4 years of Clinical and/or Drug Safety experience Or Associates degree and 8 years of Clinical and/or Drug Safety experience Or High school diploma / GED and 10 years of Clinical and/or Drug Safety experience Preferred Qualifications:Medical Qualification (BSN, PharmD, DDS/DMD, PA, or international equivalent)Knowledge of Amgen Case Management and medical review SOPs and pharmacovigilance regulatory requirements for pharmacovigilanceClinical knowledge of therapeutic area patient populations and drug classProficiency in technical safety systems including Safety Database and medical codingKnowledge of safety data capture in Clinical Trials and Post Marketing settingKnowledge of clinical trials and drug developmentKnowledge of Amgen products and patient populationThriveWhat 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 posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. 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.