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Sr. Safety Clinical Research AssociateEdwards Lifesciences - Irvine, CAExciting opportunity with the world leader in Heart Valves to advance patient care through clinical research on our Transcatheter Heart Valve Program. As a Senior Safety CRA, you will be responsible for the following: - Adverse Event handling and reviewing, according to SOP, European and FDA regulatory requirements - Determining event reportability, based on serious criteria, causality and whether the event is anticipated (per clinical protocol/IB) - Preparing adverse event reports for clinical, regulatory and complaint handling submissions, in compliance with worldwide reporting requirements (e.g., expedited UADEs, aggregate reports and other regulatory documents as requested). - Clinical safety monitoring (AE Reporting) and remote data collection (source documents collecting) to... See job listing >26 days ago from Edwards Lifesciences LLC - Save - Block - Flag - More Tools...
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Edwards Lifesciences
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Headquarters:
1 Edwards Way
Irvine, CA 92614
Phone: 949-250-2500
http://www.edwards.com - Line of Business: Mfg Surgical Appliances And Supplies
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Key Numbers:
Company Type Public (EW:NYS) Company Revenue $500M+ Company Size More than 5000 employees -
Job Location:
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