Principal,Pharmacovigilance/DeviceVigilance

Supporting the safety surveillance of In Vitro Diagnostic and Software-driven products across their lifecycle

including clinical studies and post-market activities.

and management of adverse events

and safety data for both medicinal products and medical devices

ensuring compliance with global regulatory requirements.

Ensuring compliance with global regulatory requirements (e.g.

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.

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 submission of safety reports (e.g.

Support aggregate reporting (PSUR/PBRER

Maintain and ensure compliance with global PV regulations (FDA

Contribute to signal detection and risk management activities.

and assess product complaints and adverse events related to genetic and diagnostic testing

or misinterpreted results.

Evaluate reportability of events under FDA (MDR)

Japan and other global regulations.

Prepare and submit Medical Device Reports (MDRs) and vigilance reports within regulatory timelines.

Collaborate with laboratory operations

and software teams to investigate root cause (e.g.

variant interpretation

Support post-market surveillance activities

and periodic safety reporting.