Clinical Safety Analyst (Belvidere,IL) - (Belvidere, IL)

Essential responsibilities Includes: Triages incoming SAE details in order to fulfill timely reporting according to the authority/regulatory qualifications. Participate in safety surveillance activities for assigned products; and also in area projects/goals. Identify and escalate problems to manager. Collecting, analyzing, and triaging Adverse Events including reporting Serious Adverse Events to IND safety including follow-up. Timely assessment of adverse event coding for consistency and accuracy of coding. Timely, accurate and effective medical review of safety-related CRFs and labs, including communication with Study Designated Physicians. Interface with study manager, Clinical Research Organizations, Clinical Research Associates, Data Management, and Pharmacovigilance to assure query resolution. Creation of narratives of serious adverse events and other identified adverse events of interest in accordance with accepted standards and with minimal revision required upon review.