Senior PV Scientist
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.
- Owes oversight of end-to-end PV service providers, including governance meetings, KPI monitoring, TMF documentation, and continuous process improvement. Ensures quality, timeliness, and regulatory compliance at all times.
- Contributes to the development and evolution of PV SOPs, safety management plans, and database migrations. Leads or supports implementation of new safety tools (e.g., signal detection platforms, monitoring systems) to strengthen proactive surveillance.
- Supports signal detection activities, literature review, aggregate report preparation, and safety governance meetings. Authors signal assessments, benefit-risk evaluations, and health hazard evaluations with scientific rigor and clarity.
- Prepares and/or QC safety narratives, regulatory safety responses, IND/NDA/MAA components, and DSMB materials. Ensures TMF documentation is complete, accurate, and inspection ready. Maintains compliance with global safety reporting requirements.
- Collaborates 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.
- Ensures safety data exchange complies with partner agreements. Authors searches for strategies for regulatory queries and internal requests. Maintains 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 pharmacovigivalence 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.
Annualized Base Salary
$136,000 - $156,000 USD
Company Overview
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.
Diversity, Equity & Inclusion
Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.
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