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Global Safety Medical Director

Company: Amgen
Location: Thousand Oaks
Posted on: March 22, 2020

Job Description:

Amgen is seeking a Global Safety Medical Director at its main headquarters in Thousand Oaks, California to join the Global Patient Safety (GPS) organization reporting to the Executive Medical Director Global Safety. Other remote locations may be considered.The Global Safety Therapeutic Areas 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.-- Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.The Global Safety Officer (GSO) serves 2 roles:Safety expert of the assigned product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities and is accountable for the overall safety profile and all product-related decisions and deliverables for assigned products.The GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). The GSO also is a member of the Evidence Generation Team and other relevant cross functional teams. The GSO will be assigned as delegate for the Therapeutic Area Head (TAH) as needed and has management of Global Safety Physicians.KEY ACTIVITIESValidate safety signals and lead safety signal assessmentsDevelop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.)Prepare/review core and regional risk management plans including additional risk minimization measuresPrepare/review safety sections of periodic aggregate reportsProvide safety input to protocols, statistical analysis plans, and clinical study reportsPrepare/review safety sections of new drug applications and other regulatory filingsServe as safety expert on Evidence Generation Team for assigned productsInspection ReadinessTravel: Domestic and International travel up to 10% may be essentialBasic QualificationsMD or equivalent degree from an accredited medical school with 2 or more years of industry pharmacovigilance (PV) experienceANDCompletion of an accredited medical or surgical residencyORClinical experience in either an accredited academic setting or private practice (including hospital based) settingPreferred QualificationsProduct safety in the bio/pharmaceutical industry or regulatory agencyPrevious management and/or mentoring experienceBoard Certification or equivalent trainingExpertise in Inflammation and Nephrology, Cardiovascular, Bone or Oncology

Keywords: Amgen, Thousand Oaks , Global Safety Medical Director, Executive , Thousand Oaks, California

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