Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at and follow us on LinkedIn and X.
About This Role Axsome Therapeutics is seeking a Senior Manager, Pharmacovigilance (PV) Operations to develop KPIs which are relevant to measure quality of the PV system. The Senior Manager, PV Operations is responsible for oversight of the PV Compliance system, including monitoring case processing KPIs, monitoring ICSR submission timeline, monitoring ICSR reconciliation activities, creating and maintaining SOPs and / or WIs, contractual agreements involved PV activities, facilitating the periodic safety report activities, and ensuring inspection readiness. The Senior Manager, PV Operations will report directly to the Senior Director, PV Operations and will work cross-functionally with different departments, including Clinical Development, Commercial, Medical Information, Medical Affairs, Quality, Regulatory and Legal, as well as multiple external Service Providers. This role is based at Axsome's HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles. Job Responsibilities and Duties include, but are not limited to, the following:
Requirements / Qualifications
Experience and Knowledge
Salary & Benefits (HR will complete)
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