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Principal, Pharmacovigilance / Device Vigilance

3 weeks ago
United States
Full-time
Lead
Operations Specialist
Project and Program Management
Apply Now
Natera

Natera

Natera specializes in cell-free DNA testing, providing advanced genetic testing services for oncology, women's health, and organ health to help families diagnose and manage genetic diseases.

Pharmaceuticals
1K-5K
Founded 2004
View All Jobs 95

Description

  • Perform case intake, triage, processing, and medical review coordination for Individual Case Safety Reports (ICSRs) and adverse events.
  • Process and evaluate adverse events related to diagnostic use, including the clinical impact of false positive and false negative results.
  • Coordinate timely submission of safety reports such as MedWatch, EudraVigilance, CIOMS, and Medical Device Reports (MDRs).
  • Support aggregate and periodic safety reporting, including PSUR/PBRER, DSUR, annual reports, and other post-market reporting activities.
  • Review, triage, and assess product complaints and reportable events for genetic and diagnostic testing under global vigilance regulations.
  • Collaborate with laboratory operations, bioinformatics, software, engineering, data science, Regulatory Affairs, Quality, and Medical Affairs teams to investigate root causes and corrective actions.
  • Assess software- and algorithm-related safety events, including data processing issues, algorithm errors, and reporting inaccuracies.
  • Contribute to signal detection, trend analysis, risk management, hazard analysis, and updates to risk files and FMEA documentation.
  • Ensure compliance with SOPs, GVP, QMS, and applicable global regulatory requirements across pharmacovigilance and device vigilance activities.
  • Maintain accurate documentation in safety databases and support audits, inspections, and vendor oversight.

Requirements

  • Bachelor’s degree in a life science field such as biology, microbiology, chemistry, engineering, medical technology, or regulatory science, or equivalent.
  • Advanced degree in life sciences or an MBA is preferred.
  • Minimum of 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 requirements.
  • Experience with safety databases such as AEMS, Argus, ARISg, or Veeva Safety.
  • Familiarity with MedDRA coding and case processing workflows.
  • Knowledge of applicable standards, including ISO 13485 and ISO 14971.
  • Experience in diagnostics or combination products is preferred.
  • Prior audit or inspection experience is preferred.
  • RAC, PV certification, or similar credentials are preferred.
  • Strong analytical and clinical assessment skills.
  • Excellent written and verbal communication skills, including the ability to communicate across cultures.
  • Ability to manage multiple priorities and deadlines in complex, rapidly changing environments.
  • Computer literacy with PC, Microsoft Office, and Google Workspace.

Benefits

  • Competitive pay range of $160,700 to $200,850 USD for Remote USA.
  • Comprehensive medical, dental, vision, life, and disability coverage for eligible employees and dependents.
  • Free testing for employees and their immediate families.
  • Fertility care benefits.
  • Pregnancy and baby bonding leave.
  • 401(k) benefits.
  • Commuter benefits.
  • Generous employee referral program.

Interested in this position?

Apply directly on the company website

Apply Now

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