Medical Reviewer/Safety Reviewer in Abbott Park, IL

• Pharma experience is required
• MUST BE AN RN.
• TA is Oncology
• Reviews safety-related data from clinical trials for content, quality, adherence to regulatory guidance and protocols
• Triages SAE information in order to fulfill timely reporting according to the authority/regulatory requirements
• Participates in applicable safety surveillance activities for assigned products
• Collects, analyzes, and triages AEs including reporting SAEs to IND safety
• Assessment of AE coding for consistency and accuracy of coding. Medical review of safety-related CRFs and labs, including communication with Study Physicians
• Interface with study manager, CROs, CRAs, Data Management, and PV to assure query resolution
• Creation of narratives of SAEs and other identified AEs of interest in accordance with accepted standards and with minimal revision required upon review
• Broader knowledge of ICH/FDA regulations and guidelines affecting drug safety issues preferred. Computer proficient (Windows, Word, Excel)
• Able to present adverse event data, orally and in writing

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