Principal, Pharmacovigilance, Device Vigilance

Natera

Principal position at Natera focusing on pharmacovigilance and compliance in diagnostics and medical devices. Overseeing safety data management and regulatory adherence for innovative genetic testing solutions.

Posted 6/29/2026full-timeRemote • 🇺🇸 United StatesLead💰 $160,700 - $200,850 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance and device vigilance, ensuring compliance with global safety regulations and effective management of adverse events. Proficient in case processing, medical review, and aggregate reporting within the context of In Vitro Diagnostic and software-driven products.

Highest-signal resume keywords

Pharmacovigilance ExperienceGlobal Safety Regulations KnowledgeSafety Database ProficiencyMedDRA Coding FamiliarityAdverse Event Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Case ProcessingAdverse Event AssessmentIndividual Case Safety Reports (ICSRs)Medical Device Reports (MDRs)Aggregate Reporting

Tools & Technologies

AEMSArgusARISgVeeva Safety

Industry Keywords

FDAEU IVDRJapan RegulationsISO 13485ISO 14971

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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