Head of Pharmacovigilance - AI-Driven Safety Leader (Remote)

Praxis Precision Medicines; United States; Remote; USD 378,000 - 420,000; Full time

Benefits offered by this job

401(k) match

Stock incentives

Discretionary quarterly bonus

Job summary

Praxis Precision Medicines seeks a Head of Pharmacovigilance to lead its in-house PV function across clinical development and commercial products. You will own the AI-enabled safety database, drive safety strategy, and ensure compliance with regulatory standards.

This role entails building a high-caliber team and coordinating with Clinical, Regulatory, Quality, Medical Affairs, and Commercial to safeguard patient safety.

Qualifications

• Physician with 12+ years pharmacovigilance experience.
• Experience building in-house PV systems and leading cross-functional teams.
• Strong knowledge of ICH E2A/E2B and FDA safety reporting.
• Excellent oral and written English communication.

Responsibilities

• Lead pharmacovigilance across clinical development and commercial products.
• Oversee safety data systems, quality, and compliance.
• Direct medical decisions for safety and benefit-risk assessments.
• Build and mentor PV team; manage vendor relationships and governance.

Skills

Leadership

Strategic thinking

Cross-functional collaboration

English communication

Regulatory awareness

Education

MD/DO or non-US equivalent

Tools

AI-enabled safety database

Job description

Praxis Precision Medicines seeks a Head of Pharmacovigilance to lead its in-house PV function across clinical development and commercial products. You will own the AI-enabled safety database, drive safety strategy, and ensure compliance with regulatory standards.

This role entails building a high-caliber team and coordinating with Clinical, Regulatory, Quality, Medical Affairs, and Commercial to safeguard patient safety.