Senior PV Scientist

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $136k - $156k / year

⏰ Full Time

🟠 Senior

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Praxis

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2002

🧬 Biotechnology

⚕️ Healthcare Insurance

🔬 Science

Biotechnology • Healthcare Insurance • Science

Praxis is a company dedicated to connecting patients with meaningful clinical trial opportunities. With a focus on creating customized recruitment programs, Praxis utilizes a variety of specialized tools and extensive experience across various therapeutic areas to ensure they reach the right patients worldwide. Established in 2002, the company emphasizes the importance of patient engagement and utilizes sophisticated data insights to enhance the patient journey in clinical research.

📋 Description

• 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. • 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. • Collaborate with Clinical Operations, Regulatory, Medical Affairs, Commercial, and Quality to ensure aligned safety processes. • Ensure safety data exchange complies with partner agreements.

🎯 Requirements

• 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.

🏖️ Benefits

• Health insurance • 401(k) retirement plans • Paid time off • Flexible work arrangements • Professional development opportunities