Associate Director, PV Scientist

The Associate Director, PV Scientist role supports the medical oversight, analysis, coding, interpretation, and reporting of pharmacovigilance data at Praxis. This role contributes to high-quality safety surveillance, signal detection, benefit-risk evaluation, and regulatory compliance across clinical development programs.

Requirements

• Serve as the U.S. facing PV leader, ensuring timely follow-up on safety actions across global teams and time zones.
• Own oversight of end-to-end PV service providers, including governance meetings, KPI monitoring, TMF documentation, and continuous process improvement.
• 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.

Benefits

• 99% of the premium paid for medical, dental and vision plans
• Company-paid life insurance
• AD&D
• Disability benefits
• Voluntary plans to personalize coverage
• Match dollar-for-dollar up to 6% on eligible 401(k) contributions
• Long-term stock incentives
• ESPP
• Discretionary quarterly bonus
• Flexible wellness benefit
• Generous PTO
• Paid holidays
• Company-wide shutdowns