Medical Reviewer/Safety Reviewer in Abbott Park, IL

• Must be an RN.
• 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, 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.

 Responsibilities

• Responsibilities include medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings.
• May manage the activities of regional contract CRAs, and organizes the files and budgets associated with several clinical studies.
• Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database.
• Off-label information would be disseminated at this level.
• May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification.

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