Role: Global Safety Senior Medical Scientist
Location: Remote
Duration: 12+ Months (Possible Extension)
Safety database (Oracle Argus, ARISg (LifeSphere), AERS)
Execute the medical review of ICSRs (narratives, coding, expectedness, causality, and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports
Case Management and Medical Review SOPs and Regulatory requirements for Pharmacovigilance
Proficiency in technical Safety Systems including the Amgen Safety Database and Medical Coding
Top 3 Must Have Skill Sets:
· Clinical knowledge of therapeutic area patient populations and drug class
· Proficiency in technical safety systems including the Amgen Safety Database and medical coding
· Knowledge of Safety Data Capture in Clinical Trials and in the Post Marketing environments
· Knowledge of Clinical Trials and Drug Development
Medical Qualification: MD/DO or international equivalent plus 3 years relevant work
Top 3 Must Have Skill Sets:
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