Natera

2 months ago

Principal, Pharmacovigilance / Device Vigilance

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 5 hours agoStatus: Live

Job Summary

Lead pharmacovigilance and device vigilance programs for In Vitro Diagnostic and software-driven products. Manage safety data, case processing, medical reviews, and regulatory submissions across FDA, EU IVDR, and Japan, partnering with QA, regulatory affairs, and engineering to ensure patient safety and compliant post-market activities.

Location: United States

Workplace: Remote

Employment Type: Full time

Job Function: Communications, PR & Community

Seniority: Mid level

Key Responsibilities

•Pharmacovigilance (Drug Safety): Perform case intake, triage, and processing of Individual Case Safety Reports (ICSRs).
•Coordinate medical review and causality assessment of adverse events and timely submission of safety reports (e.g., MedWatch, EudraVigilance, CIOMS).
•Support aggregate reporting (PSUR/PBRER, DSUR, annual reports) and maintain compliance with global PV regulations (FDA, EMA, ICH).
•IVD Device Vigilance: Review and assess product complaints and adverse events related to genetic/diagnostic testing; evaluate reportability under MDR, EU IVDR, and Japan.
•Software & Algorithm-Related Safety: Assess safety events for software in medical device systems; partner with engineering and data science teams on corrective actions.

Pay and Benefits

Perks:Health InsuranceDentalVision401kCommuter Benefits

Key Requirements

•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

Experience:12+ yearsPharmacovigilanceMedical devicesDiagnosticsSoftware

Education:Bachelor's

Skills:Analytical thinkingAttention to detailRegulatory complianceCommunicationCross-functional collaboration

Certifications:RAC

Languages:English

Tech Stack:MedDRAAEMSArgusARISgVeeva SafetyFDAEU IVDRMDRICHISO 13485ISO 14971

Company Brief

Natera

Develops and commercializes genetic testing and diagnostics focused on reproductive health, oncology, and organ transplant to inform clinical decision-making and improve patient outcomes.

Industry: Diagnostics

Company Size: Enterprise (1,001+ employees)

Revenue: USD 500M to 1B

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: San Carlos, United States

Founded: 2004

Website LinkedIn

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Natera

2 months ago

Principal, Pharmacovigilance / Device Vigilance

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 5 hours agoStatus: Live

Job Summary

Location: United States

Workplace: Remote

Employment Type: Full time

Job Function: Communications, PR & Community

Seniority: Mid level

Key Responsibilities

•Pharmacovigilance (Drug Safety): Perform case intake, triage, and processing of Individual Case Safety Reports (ICSRs).
•Coordinate medical review and causality assessment of adverse events and timely submission of safety reports (e.g., MedWatch, EudraVigilance, CIOMS).
•Support aggregate reporting (PSUR/PBRER, DSUR, annual reports) and maintain compliance with global PV regulations (FDA, EMA, ICH).
•IVD Device Vigilance: Review and assess product complaints and adverse events related to genetic/diagnostic testing; evaluate reportability under MDR, EU IVDR, and Japan.
•Software & Algorithm-Related Safety: Assess safety events for software in medical device systems; partner with engineering and data science teams on corrective actions.

Pay and Benefits

Perks:Health InsuranceDentalVision401kCommuter Benefits

Key Requirements

•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

Experience:12+ yearsPharmacovigilanceMedical devicesDiagnosticsSoftware

Education:Bachelor's

Skills:Analytical thinkingAttention to detailRegulatory complianceCommunicationCross-functional collaboration

Certifications:RAC

Languages:English

Tech Stack:MedDRAAEMSArgusARISgVeeva SafetyFDAEU IVDRMDRICHISO 13485ISO 14971

Company Brief

Natera

Develops and commercializes genetic testing and diagnostics focused on reproductive health, oncology, and organ transplant to inform clinical decision-making and improve patient outcomes.

Industry: Diagnostics

Company Size: Enterprise (1,001+ employees)

Revenue: USD 500M to 1B

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: San Carlos, United States

Founded: 2004

Website LinkedIn