Head of Pharmacovigilance

Role: Head of Pharmacovigilance (PV) leading Praxis's in-house safety system for clinical development and commercial products. Objectives: establish and oversee the PV system, ensuring compliance, safety decision-making, and inspection readiness. Responsibilities: direct PV for commercial and clinical programs, make senior medical benefit-risk determinations, build and qualify the PV team, design safety strategies, oversee signal management and risk mitigation, and manage AI-enabled safety database operations. Qualifications: MD/DO with at least 12 years of PV experience across clinical and postmarketing settings; proven leadership in PV system build, vendor management, and safety strategy; strong regulatory and medical judgment skills, including experience with safety reporting (21 CFR, ICH GVP). Preferred: background in neuroscience, rare diseases, or CNS disorders; experience transitioning PV activities in-house; advanced degrees (PhD, MPH). High-Value: senior safety medical decision authority, AI safety database governance, cross-functional collaboration with Clinical Development, Regulatory, Quality, and Medical Affairs. Work Setup: remote with travel as needed; accountable for safety system and inspection readiness across all phases.