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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 18041BRJob Posting Title Dir Global Safety - Global Safety Scientist Lead (GSSL)Career Category SafetyEmployee Subgroup Salaried FTCountry (State/Region) United States - CaliforniaLocation (City) Thousand OaksAmgen Job Description The GSS is an independent individual contributor providing deep technical and scientific expertise to one or more late phase or post-approval programs.The GSS is a core member of the Global Safety Team (GST) for assigned product(s). The GSS provides pharmacovigilance expertise through contributions, GST deliverables and activities on highly complex projects requiring a broader and more advanced level of pharmacovigilance expertise.Leads efforts to implement new and revised processes and pharmacovigilance standards across GSTs. The GSS is recognized as qualified to serve as the GST delegate for compliance and GST related activities.Key Activities:Clinical trial safety:- Review and provide strategic input on study protocols, statistical analysis plans and other clinical study-related documents- Review standard design of tables, figures, and listings for safety data from clinical studiesSignal detection, evaluation, and management:- Assist GSO in the development of signal detection strategy- Implement signal detection strategy approved by GSO- GSS

KEY REQUIREMENTS:

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Not stated