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Job Field: Security
Location: Cambridge, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Auto req 18202BRJob Posting Title Global Safety Medical DirectorCareer Category SafetyEmployee Subgroup Salaried FTCountry (State/Region) United States - CaliforniaUnited States - MassachusettsLocation (City) CambridgeThousand OaksAmgen Job Description This role provides content and technical support to the Global Safety Team in the evaluation of safety data and production of GST deliverables. Due to significant experience in the role from a scientific and technical perspective this role requires increased independence and leadership with less direct supervision of content driven activities by the GSO. The incumbent must be able to serve as GSO delegate for internal and potentially external Amgen meetings (Data Monitoring Committee, Ad-com representation).Key Activities:Support Global Safety Officer (GSO) in the clinical interpretation of safety signals and evaluations of aggregate safety data including analytical strategy and search methodologyResponsible for producing presentations for Product Safety Review Meetings (PSRM) and other scientific presentations under the guidance of the GSOContribute content support to the development of strategy and creation of product risk management plans, safety updates, safety assessment reports, and other GST deliverablesSafety content and expertise in support of Investigator Meetings, Data Monitoring Committees and DRTs, responses to regulatory authorities, safety sections of clinical trial documentsBasic Qualifications MD or DO degree from an accredited medical schoolCompletion of an accredited medical or surgical residencyORClinical experience in either an accredited academic setting or private practice (including hospital based) settingPreferred Qualifications Advanced Education in Nephrology strongly preferred.Current registered medical licenseBoard certified or Board eligibleAccredited fellowship or clinical experienceClinical experience, including trainingDrug safety experienceThis role can be filled in either our Thousand Oaks for Cambridge location

KEY REQUIREMENTS:

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Not stated