Principal, Pharmacovigilance, Device Vigilance

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $160.7k - $200.8k / year

⏰ Full Time

🔴 Lead

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Natera

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2004

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

Natera is a global leader in cell-free DNA testing technology, specializing in non-invasive genetic testing and diagnostics. The company's innovative solutions focus on areas such as prenatal screening, cancer detection, and organ transplant monitoring. By using advanced bioinformatics and DNA analysis, Natera provides healthcare professionals and patients with critical information to make more informed medical decisions.

📋 Description

• Support the safety surveillance of In Vitro Diagnostic and Software-driven products • Responsible for the collection, assessment, reporting, and management of adverse events • Ensure compliance with global regulatory requirements (e.g., FDA, EU IVDR, Japan) • Perform case intake, triage, and processing of Individual Case Safety Reports (ICSRs) • Process and evaluate adverse events associated with diagnostic use • Coordinate medical review and causality assessment of adverse events • Support aggregate reporting and maintain compliance with global PV regulations • Review, triage, and assess product complaints related to genetic and diagnostic testing • Prepare and submit Medical Device Reports (MDRs) and vigilance reports • Collaborate with laboratory operations, bioinformatics, and software teams • Assess safety events associated with software as part of a medical device system • Ensure compliance with SOPs, GVP, and applicable quality systems

🎯 Requirements

• Bachelor’s degree in life science field or equivalent • Advanced degree in life sciences (MS, PhD, etc.) and/or MBA preferred. • Minimum of 12 years of direct applicable experience in pharmacovigilance and/or device vigilance • Strong knowledge of global safety regulations (FDA, EMA, ICH, EU IVDR, Japan) • Experience with safety databases (e.g., AEMS, Argus, ARISg, Veeva Safety) • Familiarity with MedDRA coding and case processing workflows • Knowledge of applicable standards, including ISO 13485 and ISO 14971

🏖️ Benefits

• Comprehensive medical, dental, vision, life and disability plans • Free testing for employees and their immediate families • Fertility care benefits • Pregnancy and baby bonding leave • 401k benefits • Commuter benefits • Generous employee referral program