Role Description
The Principal, Pharmacovigilance / Device Vigilance is a detail-oriented and proactive professional supporting the safety surveillance of In Vitro Diagnostic and Software-driven products across their lifecycle, including clinical studies and post-market activities. This role is responsible for the collection, assessment, reporting, and management of adverse events, product complaints, and safety data for both medicinal products and medical devices, ensuring compliance with global regulatory requirements.
The position plays a critical role in ensuring compliance with global regulatory requirements (e.g., FDA, EU IVDR, Japan) and maintaining the highest standards of patient safety and product quality across both laboratory-developed tests and regulated IVD products, including software/algorithm-based components.
Qualifications
• Bachelor’s degree in life science field (biology, microbiology, chemistry, engineering, medical technology, regulatory science, etc.) or equivalent. Advanced degree in life sciences (MS, PhD, etc.) and/or MBA preferred.
• RAC 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.
Requirements
• Experience with global markets is highly desirable.
• Strong analytical and clinical assessment skills.
• Attention to detail and regulatory compliance mindset.
• Ability to manage multiple priorities and deadlines.
• Excellent written and verbal communication.
• Cross-functional collaboration.
• Demonstrated self-starter and highly motivated, energetic and enthusiastic.
• Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices, which includes analytical problem solving.
• Demonstrated organizational, planning, and program management skills, including action oriented, focused urgency and driving for results.
• Ability to be effective in complex projects with ambiguity and/or rapid change.
• Excellent written and verbal communication skills including ability to communicate across cultures.
• Work with others in a team environment; effective interactions with technical and medical personnel.
• Computer literacy (PC, Microsoft Office and Google Workspace).
Benefits
• Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
• Natera employees and their immediate families receive free testing in addition to fertility care benefits.
• Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more.
• Generous employee referral program.
Company Description
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
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