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Director, Safety Scientist
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- Lead the preparation and presentation of safety data at safety governance meetings (Safety Management Team and Company Safety Committee) and for Safety Monitoring Committee (SMC), Data Monitoring Committee (DMC)/Data and Safety Monitoring Board (DSMB)
- Lead the authoring and review of safety sections of regulatory submissions, e.g., IND/CTA (General Investigational Plans, China Risk Control Plans), NDA/MAA (SCS/ISS, RMPs, initial Package Inserts) collaborating with PSLs and other Clinical Study Team (CST) members
- Advanced knowledge working with a safety database (i.e., Argus) for retrieval of safety information
- Advanced knowledge of MedDRA and signal management system
- Advanced application capability with Excel, PowerPoint, Word, and electronic document management system (i.e., Veeva)
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