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The Principal Medical Safety Specialist is a health care professional responsible for the medical review of adverse event data across a range of products and disease states in cardiology, electrophysiology and left atrial appendage occlusion (LAAO). This individual completes accurate, timely and consistent medical assessments of adverse events and potential adverse events to provide medical expertise and objective oversight and help ensure safety vigilance throughout the total product lifecycle. This role performs medical assessments of adverse events, evaluates emerging safety signals and product performance trends, and provides clinical input into risk management, post-market surveillance and patient safety decisions. As a Medical Safety subject matter expert, this individual partners closely with the Medical Director and cross-functional teams across Quality, Regulatory, Clinical, R&D, Medical Affairs and Commercial functions to evaluate complex safety issues and support informed benefit-risk and patient safety decisions.
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Job Type
Full-time
Career Level
Principal

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