Medical Director, Neuroimmunology, Global Patient Safety

About this job

Purpose: Responsible for supporting the Product Safety Lead (PST) in overseeing the comprehensive safety surveillance of one or more neuroscience products throughout their lifecycle, including signal management, interpretation of pharmacovigilance regulations, and supporting all safety deliverables. Responsibilities: Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance Safety surveillance for pharmaceutical / biological / drug –device combination neuroscience products Contribute to the authorship of key pharmacovigilance documents, including but not limited to medical safety assessments, periodic safety reports, regulatory responses and risk management plans Apply current regulatory guidance as appropriate for…

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