Principal, Pharmacovigilance / Device Vigilance

Job description

POSITION SUMMARY: The Principal, Pharmacovigilance / Device Vigilance is a detail-oriented and proactive professional supporting the safety surveillance of In Vitro Diagnostic and Software-driven products across their lifecycle, including clinical studies and post-market activities. This role is responsible for the collection, assessment, reporting, and management of adverse events, product complaints, and safety data for both medicinal products and medical devices, ensuring compliance with global regulatory requirements. The position plays a critical role in ensuring compliance with global regulatory requirements (e.g., FDA, EU IVDR, Japan) and maintaining the highest standards of patient safety and product quality across both laboratory-developed tests and regulated IVD products, including software/algorithm-based components. PRIMARY RESPONSIBILITIES: Pharmacovigilance (Drug Safety) 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) Coordinate medical review and causality assessment of adverse events Coordinate timely submissio...