Principal, Pharmacovigilance / Device Vigilance

About the role

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)

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