Triages incoming SAE information in order to fulfill timely reporting according to the authority/regulatory requirements. 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. Work closely with study-specific contacts such as; Clinical Safety Manager, clinical research organization, clinical research associates, data management, and pharmacovigilance. Responsible for clinical safety capture and report, as workload responsibilities are study-related and have a major impact on regulatory compliance and product safety profile. Follow scientific arguments and identify safety data needs and adhere to resolution of data completeness regarding all aspects of clinical safety that impact product approval, safety signal identification, and patient safety.
Bachelor's degree with related health science background preferred, RN or clinical pharmacy experience strongly preferred. Candidates lacking the appropriate Bachelor's degree but with previous pharma experience may be additionally considered. 2 years clinical experience is required. Competent understanding of ICH/FDA regulations and guidelines affecting drug safety issues. Sound understanding of product labeling/literature, including safety profile. Able to apply clinical knowledge to adverse event data collection and assessment. Competent in ability to present adverse event data, orally and in writing. Adheres to policies and regulations. Must be Computer proficient (Windows, Word, Excel).
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