TAKEDA DEVELOPMENT CENTER AMERICAS, INC. – $120,078.00/Year

Ensure patient safety during the conduct of clinical trials by timely assessment and reporting of adverse events. Ensure timely reporting of adverse events in accordance with global regulatory requirements including but not limited to FDA, EMA, PMDA. Setup systems and processes to ensure compliance with FDA CFRCode of Federal Regulations Title 21 CFR 812 IDE Regulations governing patient safety during clinical trials. Setup systems and processes to ensure compliance with FDA CFRCode of Federal Regulations Title 21 CFR 312.32 IND Safety Reporting and global regulations governing patient safety during clinical trials. Develop procedural documents to govern pharmacovigilance in the context of clinical trials. Review metrics and Key Performance Indicators to oversee tasks performed by external vendors. H10B Sr. Mgr, Clinical Trial PV Operations Oversight, Manager, Clinical Trial PV Operations Oversight, Clinical Safety Operations Lead, Regulatory Associate, Reg Documentation Specialist, Adverse Event Reporting Associate, Clinical Submission Specialist or related position