Principal, Pharmacovigilance / Device Vigilance

📋 Description

• • **Critical Role in Patient Safety and Regulatory Compliance:** As the Principal, Pharmacovigilance / Device Vigilance at Natera, you will play a pivotal role in safeguarding patient health by ensuring the safety and efficacy of In Vitro Diagnostic (IVD) and software-driven medical products. This position is essential for maintaining compliance with global regulatory standards, including FDA, EU IVDR, and Japan regulations, and directly impacts patient outcomes by identifying, assessing, and mitigating risks associated with diagnostic errors, adverse events, and product complaints. Your work will ensure that Natera’s cutting-edge genetic and diagnostic testing products meet the highest standards of quality and safety, reinforcing the company’s mission to revolutionize disease management worldwide.
• • **Day-to-Day Responsibilities:**
• • **Case Management and Reporting:** Conduct intake, triage, and processing of Individual Case Safety Reports (ICSRs) for adverse events related to diagnostic tests, including false positives/negatives, algorithm errors, and software defects. Ensure timely submission of safety reports to regulatory bodies (e.g., FDA MedWatch, EudraVigilance, CIOMS) within strict deadlines.
• • **Regulatory Compliance:** Maintain deep knowledge of global pharmacovigilance (PV) and device vigilance regulations (e.g., FDA, EMA, ICH, EU IVDR, Japan). Evaluate reportability of adverse events and product complaints under these frameworks, ensuring adherence to SOPs, Good Vigilance Practices (GVP), and quality management systems (QMS).
• • **Cross-Functional Collaboration:** Work closely with laboratory operations, bioinformatics, software engineering, and clinical teams to investigate root causes of adverse events (e.g., assay performance issues, variant interpretation errors, software defects). Partner with Regulatory Affairs, Quality, and Medical Affairs teams to align safety practices with broader organizational goals.
• • **Risk Management and Signal Detection:** Contribute to signal detection, risk assessment, and hazard analysis for diagnostic products, including software/algorithm-based components. Update risk management files (e.g., FMEA) and support post-market surveillance activities, including trending and periodic safety reporting (e.g., PSUR/PBRER, DSUR).
• • **Documentation and Audit Support:** Maintain accurate and comprehensive documentation in safety databases (e.g., AEMS, Argus, Veeva Safety). Support internal and external audits/inspections, ensuring readiness for regulatory scrutiny and addressing findings proactively.
• • **Vendor Oversight:** Assist in managing relationships with external vendors, such as Contract Research Organizations (CROs) and safety service providers, to ensure compliance with contractual and regulatory obligations.
• • **Global Impact:** Leverage expertise in global markets to ensure consistency in safety practices across regions. Provide guidance on regional nuances in regulatory requirements and adapt processes accordingly.
• • **About Natera:** Natera is a global leader in cell-free DNA (cfDNA) testing, specializing in oncology, women’s health, and organ health. The company is dedicated to integrating personalized genetic testing and diagnostics into standard healthcare practices, enabling earlier and more targeted interventions. Natera’s team comprises world-class professionals, including statisticians, geneticists, doctors, and software engineers, who collaborate in a dynamic and mission-driven environment. Joining Natera means being part of a company that values innovation, inclusivity, and a commitment to improving patient lives worldwide.
• • **Professional Growth and Impact:**
• • **Expertise Development:** This role offers the opportunity to deepen your expertise in pharmacovigilance, device vigilance, and regulatory compliance, particularly in the rapidly evolving fields of IVD and software-driven diagnostics. You will gain hands-on experience with global regulatory frameworks and safety databases, positioning yourself as a subject matter expert.
• • **Leadership and Influence:** As a Principal-level professional, you will have the autonomy to drive critical safety initiatives, influence risk management strategies, and mentor cross-functional teams. Your contributions will directly shape Natera’s compliance posture and patient safety outcomes, making a tangible impact on public health.
• • **Innovation in Diagnostics:** Work at the intersection of healthcare and technology, where your efforts will support the development and monitoring of next-generation diagnostic tools. This role is ideal for professionals passionate about leveraging their regulatory expertise to advance precision medicine.