Perform quality assurance activities related to FDA and ROW regulations across therapeutic areas and provide regulatory guidance for all phases of drug development.
Supports the oversight and management of global business partner safety data exchange agreements/ pharmacovigiliance agreements and other contracts as applicable to ensure compliance with data exchange activity.
Communicates with partner companies and vendors regarding processing and timely exchange of safety data. Distributes aggregatereport as required and assists with reconciiliation activities.
Develop/improve and manage quality systems and processes to include.