Job Description
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...
+ 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...
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