Head of Pharmacovigilance

Scorpion Therapeutics; United States; Remote; USD 250,000 - 350,000; Full time

Job summary

Praxis is seeking a Head of Pharmacovigilance to lead our in-house safety system for clinical development and commercial products, ensuring compliance and inspection readiness.

You will direct PV for programs, shape risk management and signaling, build the PV team, and oversee AI-powered safety database operations across all phases.

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)

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
• manage AI-enabled safety database operations

Job description

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
• 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.