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Job Field: Security
Location: Thousand Oaks, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Auto req 16415BRJob Posting Title Global Safety Medical Director - OncologyCareer Category SafetyEmployee Subgroup Salaried FTCountry (State/Region) United States - CaliforniaLocation (City) Thousand OaksAmgen Job Description This is an opportunity for a Medical Director to serve in a Global Safety Officer GSO role within the Oncology Therapeutic area in Amgen Global Safety.The role is located at Amgen''s headquarters in Thousand Oaks, California.The Global Safety Medical Director (also known as the Global Safety Officer (GSO)) leads by establishing the direction and priorities of the Global Safety Team (GST) and is accountable for all product safety related GST decisions for assigned products and is the key interface between the GST, Therapeutic Area Head (TAH), Amgen Global Safety Senior Management, and other Amgen functional areas. The GSO, supported by the Global Safety Project Manager, is responsible for the timely communication of safety recommendations and/or actions from the GST to internal and external stakeholders. This role leads single projects which can be of moderate or high complexity / scope or multiple projects of lower complexity closely collaborating with the Therapeutic Area Head.Key Activities:Accountable for identification, assessment, and communication of potential safety signals as leader of GST pharmacovigilance activitiesGST representative on the PST (commercialization) accountable for GST PST deliverablesLead response to regulatory safety queriesLead development of strategy and creation of product risk management plans including maintenance and updatesAccountable for Global Safety Strategic Plan (GSSP)Safety representative for assigned products at meetings with Regulatory authorities, data safety monitoring committees, advisory boardsParticipate in planning, review and sign off of clinical trial safety documents for content including:o Clinical Summary of Safety (CSS)o 120 Day safety updateo Protocol safety sectionso CSRso ICFso Study safety monitoring planso Investigator BrochuresBasic Qualifications MD or DO degree from an accredited medical schoolPreferred Qualifications 2+ years of safety experienceCompletion of an accredited medical or surgical residencyORClinical experience in either an accredited academic setting or private practice (including hospital based) settingDrug safety, biotech/pharmaceutical or regulatory agency experienceBoard Certification by an accredited medical or surgical board e.g. ABIM, ABMS, EUMS

KEY REQUIREMENTS:

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