Praxis Precision Medicines
Senior PV Scientist
United States - Remote
Role brief
What this role is asking for.
Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity As Praxis advances its pipeline and prepares for regulatory submissions, this position plays a critical role in strengthening U.S.-based pharmacovigilance footprint, enhancing vendor oversight, supporting implementation of evolving safety infrastructure, and ensuring inspection readiness. The PV Scientist enables the PV Lead to focus on clinical safety strategy, regulatory submission activities, and labeling development by providing both strategic and operational support across safety activities. Primary Responsibilities Serve as the U.S. facing PV leader, ensuring timely follow-up on safety actions across global teams and time zones. Proactively identify and resolve operational gaps before they become compliance risks. Own oversight of end-to-end PV service providers, including governance meetings, KPI monitoring, TMF documentation, and continuous process improvement. Ensure quality, timeliness, and regulatory compliance at all times. Contribute to the development and evolution of PV SOPs, safety management plans, and database migrations. Lead or support implementation of new safety tools (e.g., signal detection platforms, monitoring systems) to strengthen proactive surveillance. Support signal detection activities, literature review, aggregate...
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