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关于会员

个人简介

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.

教育经历

  • Louisiana Tech University
    学位 Master of Science in Biology
    专业 College of applied and natural Sciences
    开始日期 01/2011
    结束日期 01/2013

工作经验

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