Principal, Pharmacovigilance – Device Vigilance

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🕒 August 6

🇺🇸 United States – Remote

💵 $160.7k - $200.8k / year

⏰ Full Time

🔴 Lead

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Natera

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2004

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

Healthcare • Biotechnology • Healthcare Insurance

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 safety surveillance of in vitro diagnostic and software-driven products across clinical studies and post-market activities • Collect, assess, report, and manage adverse events, product complaints, and safety data for medicinal products and medical devices • Perform case intake, triage, and processing of Individual Case Safety Reports • Process and evaluate adverse events associated with diagnostic use • Coordinate medical review and causality assessment • Coordinate submission of safety reports, including MedWatch, EudraVigilance, and CIOMS • Support aggregate reporting, signal detection, and risk management activities • Review and assess product complaints and adverse events related to genetic and diagnostic testing • Evaluate reportability under FDA MDR, EU IVDR, Japan, and other global regulations • Prepare and submit Medical Device Reports and vigilance reports • Investigate root causes with laboratory operations, bioinformatics, and software teams • Assess software and algorithm-related safety events and support corrective actions • Contribute to hazard analysis, risk files, and FMEA updates • Ensure compliance with SOPs, GVP, and applicable quality systems • Partner with Clinical, Regulatory Affairs, Quality, and Medical Affairs teams • Support internal and external audits and inspections • Maintain safety database documentation and assist with vendor oversight • Provide support outside standard business hours for expedited reporting requirements as needed

🎯 Requirements

• Bachelor’s degree in a life science field or equivalent • Minimum 12 years of direct applicable experience in pharmacovigilance and/or device vigilance • Strong knowledge of global safety regulations, including FDA, EMA, ICH, EU IVDR, and Japan • Experience with safety databases such as AEMS, Argus, ARISg, or Veeva Safety • Familiarity with MedDRA coding and case-processing workflows • Knowledge of ISO 13485 and ISO 14971 • Strong analytical and clinical assessment skills • Regulatory compliance mindset and attention to detail • Ability to manage multiple priorities and deadlines • Excellent written and verbal communication skills • Ability to communicate across cultures and collaborate cross-functionally • Organizational, planning, and program management skills • Ability to work effectively on complex projects involving ambiguity or rapid change • Computer literacy, including PC, Microsoft Office, and Google Workspace

🏖️ Benefits

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