Our Client, a Clinical-Stage Cell Therapy company, is looking for a Manager, Pharmacovigilance Safety Operations for their Bothell, WA/ /CA/Remote location. Responsibilities:

+ Represent Patient Safety as a Study Management Team member

+ Interface with the Study Management Team, safety service provider, and medical safety reviewer to maintain safety processes supporting assigned studies

+ Assist with safety data case processing oversight

+ Manage review and revision of safety language in relevant study documents

+ Prepare and maintain safety management plans

+ Contribute to service provider oversight

+ Assess changes to the ICF safety information by sites and IRBs

+ Assist with the preparation and management of aggregate reports such as the Development Safety Update Report

+ Prepare and contribute to written processes supporting pharmacovigilance activities

+ Assist in maintaining p...