Principal, Pharmacovigilance / Device Vigilance

TL;DR

Principal, Pharmacovigilance / Device Vigilance (Medtech): Supporting safety surveillance of In Vitro Diagnostic and software-driven medical products across lifecycle with an accent on adverse event collection, assessment, reporting, and compliance with global regulations. Focus on processing ICSRs, preparing MDRs and vigilance reports, conducting signal detection, and collaborating on root cause investigations with cross-functional teams.

Location: US Remote

Salary: $160,700–$200,850 USD

Company

Global leader in cell-free DNA testing dedicated to oncology, women’s health, and organ health.

What you will do

• Perform case intake, triage, processing, and medical review of Individual Case Safety Reports (ICSRs) for pharmacovigilance.
• Review, assess, and report product complaints and adverse events for IVD device vigilance under FDA MDR, EU IVDR, and global regulations.
• Evaluate and report safety events related to software/algorithms, partnering with engineering and data science teams.
• Support aggregate reporting, signal detection, risk management, and post-market surveillance activities.
• Ensure compliance with SOPs, GVP, QMS, and contribute to audits, inspections, and vendor oversight.
• Maintain accurate documentation in safety databases and provide support outside standard hours as needed.

Requirements

• Bachelor’s degree in life sciences or equivalent; minimum 12 years in pharmacovigilance and/or device vigilance
• Strong knowledge of global regulations (FDA, EMA, ICH, EU IVDR, Japan)
• Experience with safety databases (AEMS, Argus, ARISg, Veeva Safety)
• Familiarity with MedDRA coding, case processing, ISO 13485, and ISO 14971
• Analytical skills, attention to detail, and ability to manage priorities and deadlines
• Excellent communication and cross-functional collaboration skills

Nice to have

• Advanced degree (PharmD, MD, MPH, MSc) or MBA
• RAC, PV certification, or similar credentials
• Experience in diagnostics, combination products, or audits/inspections

Culture & Benefits

• Comprehensive medical, dental, vision, life, and disability plans
• Free testing for employees and families, fertility care, pregnancy/baby bonding leave
• 401k, commuter benefits, generous employee referral program
• Work alongside statisticians, geneticists, doctors, and software engineers
• Focus on growth, challenge, and changing genetic disease management