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Senior Manager, Drug Safety

Supernus Pharmaceuticals · Rockville, Maryland, US

Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that...

Job description

Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes. Job Summary: The Senior Manager of Drug Safety will support drug safety and pharmacovigilance operations to ensure the consistency and accuracy of adverse event reporting in clinical studies including initial safety review of adverse events and medical review of clinical data, interaction with drug safety vendors, review of source documents, and preparation of documents for submission to regulatory authorities. Essential Duties & Responsibilities: - Participate in the operational aspects of adverse event reporting for all investigational products. - Ensure consistency in the evaluation and assessment of adverse event reports and source documentation for completeness, accuracy and legibility. -...