Safety Vigilance Specialist - ¿Ü±¹°è ÀÇ·á±â±âȸ»ç
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• Monitors all the complaints
• Review and verify the accuracy of translations to ensure that medical terminology.
• Maintain a comprehensive tracker for all regulatory submissions, detailing submission dates, document versions, and any feedback or requests received from the health authority.
• Prepare the safety documents required by local regulations.
• Monitor Enterprise Complaint Management (ECM) system on a regular basis to ensure no Adverse Events(AE) or urgent safety issue is missed, and to maintain a timeline for regulatory reporting.
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• 2-5 years of experience in Safety Vigilance (+ Adverse Events)
• Fluent communication skill in Korean and English
• Statistical Knowledge and Analysis
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