Startseite
SG

Über das Mitglied

Biografie

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.

Ausbildung

  • Louisiana Tech University
    Abschluss Master of Science in Biology
    Studienrichtung College of applied and natural Sciences
    Startdatum 01/2011
    Enddatum 01/2013

Berufserfahrung

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