- Insight Global (Mundelein, IL)
- Job Description Insight Global is seeking a qualified Adverse Event Specialist to join an established medical device company in Mundelein, IL. This ... medical descriptions, product information, and complaint narratives to determine event severity and regulatory obligations. Experience in a regulated industry… more
- Edwards Lifesciences (Chicago, IL)
- …technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, ... regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities. Act as a mentor to new or junior level employees + Provide oversight of and insights into trial activities (eg, trends in protocol… more
- Parexel (Springfield, IL)
- …**Key Accountabilities:** **General** + Maintaining a good working knowledge of the Adverse event /Safety profile of assigned products, labeling documents, data ... and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting + Communicating and discussing issues related to… more
- Parexel (Springfield, IL)
- …(SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with ... and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a...Partners with other Study Team members (eg Clinician, Recruitment Specialist , Clinical Data Scientist) + May act as a… more
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