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