Principal, Pharmacovigilance / Device Vigilance

📋 Description

• Lead safety surveillance for regulated diagnostic products and software-driven medical tech.
• Oversee adverse event intake, triage, evaluation, and ICSR processing.
• Coordinate medical reviews and regulatory safety reports (MedWatch, EudraVigilance, CIOMS).
• Support aggregate reporting (PSUR, PBRER, DSUR, annual safety reports).
• Ensure global PV compliance with FDA, EMA, ICH, and ISO standards.
• Lead device vigilance reviews, reportability, and post-market surveillance.

🎯 Requirements

• Bachelor’s degree in life sciences or related field (advanced degree preferred).
• 12+ years in pharmacovigilance, device vigilance, or regulatory roles.
• Strong knowledge of FDA/EMA/ICH/IVDR/Japan safety regulations.
• Experience with safety databases: AEMS, Argus, ARISg, Veeva Safety.
• Familiar with MedDRA coding and case processing workflows.
• Knowledge of ISO 13485 and ISO 14971 quality/risk standards.

🎁 Benefits

• Competitive annual salary range of $160,700 - $200,850 USD for remote U.S. employees.
• Medical, dental, vision, life, and disability insurance plans.
• Healthcare support programs and family-focused benefits.
• 401(k) retirement plan and financial wellness resources.
• Paid parental leave and baby bonding leave.
• Commuter benefits and employee support programs.