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Principal, Pharmacovigilance, Device Vigilance
NateraPrincipal 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.
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
ATS Keywords
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Hard Skills & Tools
Case ProcessingAdverse Event AssessmentIndividual Case Safety Reports (ICSRs)Medical Device Reports (MDRs)Aggregate Reporting