Global Safety Physician

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The Global Safety Physician is responsible for the following:Directs the planning, preparation, writing and review of portions of aggregate reportsOrganise and direct liaison activities with affiliates and other internal Amgen partners regarding productsSupports and provides oversight with regards to safety in clinical trials toReview and provide input on study protocols, statistical analysis plans, provide safety contents for regulatory filings. Reviews safety tables, figures, and listings from clinical studies.Support activities related to new drug applications and other regulatory filingsPerform Signal detection, evaluation, and managementAuthor Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO and pharmacovigilance scientistPrepare presentations to the Global Safety Team on safety issuesAssist GSO in the development of risk management strategy and activities, and safety-related regulatory activitiesMust have:MD or equivalent degree from an accredited medical schoolPreferred: Clinical experience in either an accredited academic setting or private practice (including hospital based) settingClinical/medical research experienceProduct safety in the bio/pharmaceutical industryInflammation and nephrology knowledge Please click here to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales