Principal, Pharmacovigilance / Device Vigilance

Primary Responsibilities

• Perform case intake, triage, and processing of Individual Case Safety Reports (ICSRs)
• Process and evaluate adverse events associated with diagnostic use (e.g., clinical impact of false positives/negatives)
• Capture and assess adverse events associated with software as part of a medical device system, including algorithm errors, data processing issues, and reporting inaccuracies
• Coordinate medical review and causality assessment of adverse events
• Coordinate timely submission of safety reports (e.g., MedWatch, EudraVigilance, CIOMS)
• Support aggregate reporting (PSUR/PBRER, DSUR, annual reports)
• Collaborate with laboratory operations, bioinformatics, and software teams to investigate root cause (e.g., assay performance, variant interpretation, software defects)
• Support post-market surveillance activities, including trending, signal detection, and periodic safety reporting
• Assess safety events associated with software as part of a medical device system, including algorithm errors, data processing issues, and reporting inaccuracies
• Partner with engineering and data science teams to evaluate software-related complaints and implement corrective actions
• Contribute to risk management activities (e.g., hazard analysis, risk files, FMEA updates) for software and integrated diagnostic systems
• Ensure compliance with SOPs, GVP, and applicable quality systems (QMS)
• Partner with Clinical, Regulatory Affairs, Quality, and Medical Affairs teams
• Support audits and inspections (internal and external)
• Maintain accurate documentation in safety databases
• Afford support outside of standard business hours for expedited reporting requirements as needed

Qualifications

• 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.
• Knowledge of applicable standards, including ISO 13485 and ISO 14971.
• Advanced degree (PharmD, MD, MPH, MSc) preferred.
• Experience in diagnostics or combination products.
• Prior audit/inspection experience preferred.
• RAC, PV certification, or similar credentials preferred.

Knowledge, Skills, and Abilities

• Experience with global markets is highly desirable.
• Strong analytical and clinical assessment skills.
• Attention to detail and regulatory compliance mindset.
• Ability to manage multiple priorities and deadlines.
• Excellent written and verbal communication.
• Strong cross-functional collaboration skills.
• Computer literacy (PC, Microsoft Office and Google Workspace).