12 Month Contract - Global Safety Senior Manager - Remote

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The Global Safety Senior Manager is responsible for the following:Work with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations.Provide scientific and compliance expertise to Global Patient Safety Search and review adverse event 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 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 Assist GSO in the development of risk management strategy and activitiesAssist GSOs to oversee risk minimization activities including tracking of activities;Support activities related to new drug applications and other regulatory filingsProvide support for clinical trials to review and provide input to study-related documentsUndertake activities delegated by the QPPV as detailed in the 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.Must have:Doctorate 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 experiencePlease 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