Aileen (Kim) Nguyen

Aileen Nguyen is a senior pharmacovigilance associate with 20 years of experience managing pharmacovigilance and regulatory affairs activities in clinical research environments.

Ms. Nguyen provides support and oversight for serious adverse event report processing, safety database management, development and review of pharmacovigilance procedures,  medical writing tasks, pharmacovigilance-related consultation and training, and other activities. As a senior regulatory affairs associate at Westat, she  developed protocol registration processes for new projects, prepared submissions for FDA and other regulatory authorities, maintained regulatory and safety management documentation,  and developed and reviewed regulatory procedures.

In her previous work as a hospital IRB administrator, Ms. Nguyen managed all IRB activities, kept detailed records of all protocol-related activities, and reviewed and audited regulatory documentation. As a regulatory affairs manager, she prepared and submitted IRB materials, maintained regulatory documents, distributed study materials to investigators, and made site visits to address regulatory issues and ensure investigator compliance.

Education

BS, Sociology, University of Maryland