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メンバー概要

自己紹介

Currently serving as an Associate Director in Clinical Development Quality, with experience across Clinical Development Quality, Pharmacovigilance Operations, and PV Quality. Provides quality and safety oversight for global clinical trials and post-marketing programs across oncology, cardiovascular, metabolic, renal, bone, pediatric, and rare disease therapeutic areas. Expertise includes inspection readiness, risk-based quality management, GCP and GVP compliance, PV operations and PV vendor oversight, CAPA management, and cross-functional collaboration across clinical operations and drug safety. Serves as a peer reviewer for JMIR journals.

学歴

  • Louisiana Tech University
    学位 Master of Science in Biology
    専攻 College of applied and natural Sciences
    開始日 01/2011
    終了日 01/2013

職歴

TA

Lead, Pharmacovigilance & Medical Quality Operations

Takeda •

01/2020 – 01/2022 •

Pharmacovigilance & Medical

B(

Manager, Pharmacovigilance & Global Medical Information

Biogen (United States) •

01/2016 – 01/2022 •

Medical Information and PV