Takeda Pharmaceuticals
Clinical Safety Operations Lead
Shire
Clinical Safety Operations Lead
Rqmis Inc. Aug 2016 - Sep 2017
Clinical Trial Associate
Timi Study Group Jan 2016 - Jun 2016
Regulatory Documentation Specialist
Merck Apr 2015 - Sep 2015
Adverse Event Reporting Associate-Ii- Co-Op
Education:
Harrisburg University of Science and Technology 2017 - 2019
Masters, Project Management
Northeastern University 2014 - 2016
Masters
University of Mumbai 2009 - 2011
Master of Science, Masters, Biochemistry
Skills:
Regulatory Affairs Clinical Trials Ich Gcp Life Sciences Microsoft Office Pharmaceutical Industry Fda Clinical Research 21 Cfr Part 11 Protocol Medical Devices Microsoft Excel Regulatory Submissions Gmp Team Management Pharmacovigilance Sop Patents Intellectual Property U.s. Food and Drug Administration Trial Management Adverse Event Reporting Medra Sop Development Protocol Development Good Clinical Practice
University of Mumbai Mumbai, Maharashtra 2010 to 2011 Post Graduate Diploma in Drug Regulatory AffairsUniversity of Mumbai, India Mumbai, Maharashtra 2009 to 2011 Masters of Science in BiochemistryUniversity of Mumbai Mumbai, Maharashtra 2006 to 2009 Bachelor of Science in Biochemistry & Microbiology