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 report preparation, and safety governance meetings. Author signal assessments, benefit-risk evaluations, and health hazard evaluations with scientific rigor and clarity.
• Prepare and/or QC safety narratives, regulatory safety responses, IND/NDA/MAA components, and DSMB materials. Ensure TMF documentation is complete, accurate, and inspection ready. Maintain compliance with global safety reporting requirements.
• Collaborate with Clinical Operations, Regulatory, Medical Affairs, Commercial, and Quality to ensure aligned safety processes, including call center setup, partner safety data exchange, and commercialization readiness activities.
• Ensure safety data exchange complies with partner agreements. Author searches for strategies for regulatory queries and internal requests. Maintain rigorous documentation standards to support inspections and audits.

Qualifications and Key Success Factors

• Nurse, Nurse Practitioner, Pharmacist, or Allied Health Professional.
• Minimum 3-5 years of experience in pharmacovigilance within the pharmaceutical/biotechnology industry.
• At least 1 year of clinical trial experience highly desirable.
• Experience with regulatory filings (INDs, NDAs, MAAs).
• Strong knowledge of FDA, EMA, ICH, and GVP pharmacovigilance regulations.
• Experience in individual case safety reporting (clinical and post-marketing), aggregate reporting, signal detection, risk management planning, regulatory inspections, and PV SOP development.
• Experience implementing safety databases and signal detection tools preferred.
• Familiarity with MedDRA and WHO-Drug coding.
• Excellent written and verbal communication skills.