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Global Pharmacovigilance Scientist Global Safety Manager

Cambridge, MA

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Amgen is seeking a Global Safety Manager to function as a Global Pharmacovigilance (PV) Scientist at its Cambridge, MA location to join the Global Patient Safety & Labeling (GPS&L) group. The Global PV Scientist will report to the Global Safety Director.The Global PV Scientist works with the Therapeutic Area Safety Teams, which serve as the safety experts for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product. The Global PV Scientist contributes to safety assessment activities for medical/scientific operations and provides scientific and compliance expertise as needed to GPS&L.Key Activities for the Global Safety Manager include: Contributes to the planning, preparation, writing and review of safety portions of aggregate reportsReview of adverse events and serious adverse events from clinical trials as neededContributes under the direction of the Global PV Sr. Scientist or Lead to:Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detectionPerform data analysis to evaluate safety signals and write up analysis results in collaboration with Global Safety OfficerPrepare safety assessment reports and other safety documents and regulatory responsesParticipate in Safety Governance per Amgen processesAssist Global Safety Officer in the development of risk management strategy and activitiesReview and provide input and support on clinical study-related documents (eg, study protocols; statistical analysis plans; and design of tables, figures, and listings for safety data from clinical studies) and attend study team meetings as requested or neededBasic Qualifications Doctorate degreeORMasteru00e2u20acu2122s degree and 3 years of biotech or pharmaceutical experienceORBacheloru00e2u20acu2122s degree and 5 years of biotech or pharmaceutical experienceORAssociateu00e2u20acu2122s degree and 10 years of biotech or pharmaceutical experienceORHigh school diploma / GED and 12 years of biotech or pharmaceutical experiencePreferred Qualifications BS or BA in Life Science1 year Drug Safety ExperienceExperience in Signal detection, evaluation and managementExperience as a contributor to periodic safety reportsGood clinical and scientific judgmentClinical and/or medical research experienceExcellent written and oral communication skillsAmgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peopleu00e2u20acu2122s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worldu00e2u20acu2122s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.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, or disability status.

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