Praxis Precision Medicines, Inc.
Senior PV Scientist
United States - Remote · Senior
Sponsorship not specified$136k-$156kDetected 63 days ago
CompliancePharmacy PracticeFDA RegulatoryPharmacovigilanceCommunication
About the role
- 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.
- Ensure quality, timeliness, and regulatory compliance at all times.
Responsibilities
- 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.
- 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.
- 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.
- Own oversight of end-to-end PV service providers, including governance meetings, KPI monitoring, TMF documentation, and continuous process improvement.
- 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.
- Maintain compliance with global safety reporting requirements.
- Ensure safety data exchange complies with partner agreements.
- Maintain rigorous documentation standards to support inspections and audits.
Requirements
- Minimum 3-5 years of experience in pharmacovigilance within the pharmaceutical/biotechnology industry.
- Experience with regulatory filings (INDs, NDAs, MAAs).
- Strong knowledge of FDA, EMA, ICH, and GVP pharmacovigilance regulations.
- Familiarity with MedDRA and WHO-Drug coding.
- Nurse, Nurse Practitioner, Pharmacist, or Allied Health Professional.
- At least 1 year of clinical trial experience highly desirable.
- Experience in individual case safety reporting (clinical and post-marketing), aggregate reporting, signal detection, risk management planning, regulatory inspections, and PV SOP development.
Nice to have
- Experience implementing safety databases and signal detection tools preferred.
Skills
- Excellent written and verbal communication skills.
Compensation
- Annualized Base Salary
Benefits
- Author signal assessments, benefit-risk evaluations, and health hazard evaluations with scientific rigor and clarity.
Company info
- 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.
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