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Role Description

This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

Reporting to the Head of Pharmacovigilance, the Associate Medical Director, PV Scientist 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.

As Praxis advances its pipeline and prepares for regulatory submissions, this position plays a critical role in strengthening U.S.-based pharmacovigilance footprint, enhancing vendor oversight, supporting implementation of evolving safety infrastructure, and ensuring inspection readiness. The Associate Medical Director, 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.

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.
• 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.
• 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.
• 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.

Qualifications

• 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.

Key Success Factors at Praxis

• Ownership mindset: You act like the safety infrastructure is yours. You don’t wait for direction to solve problems.
• Operational rigor: You create clarity in ambiguity and ensure documentation withstands inspection scrutiny.
• Scientific judgment: You understand the difference between noise and signal and contribute meaningfully to benefit-risk discussions.
• Speed with precision: You move quickly without sacrificing quality.
• Cross-functional credibility: You build trust across Clinical, Regulatory, Medical Affairs, Commercial, and external partners.
• Builder mentality: You enjoy scaling systems, not just operating within them.
• Candid communicator: You raise risks early, directly, and constructively.

Compensation & Benefits

• 99% of the premium paid for medical, dental and vision plans.
• Company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage.
• Dollar-for-dollar match up to 6% on eligible 401(k) contributions.
• Long-term stock incentives and ESPP.
• Discretionary quarterly bonus.
• Extremely flexible wellness benefit.
• Generous PTO, paid holidays, and company-wide shutdowns.
• Joining a phenomenal crew of colleagues who are smart, engaged, and inspiring.

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.