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Process Management &Safety System Expert

Synthorx

Synthorx

Tokyo, Japan
Posted on Jul 2, 2024

JOB SUMMARY: Support to manage venders’ activities to enhance quality in accordance with contract, QDs, and regulations. Main tasks of the position are below.
• Responsible for in― bound operation regarding all safety information such as domestic cases, foreign cases, literature/foreign safety measure
• Monitoring, consultation and guidance of intake and Book-in status
• Change management of AEGIS user manual and vender manuals
• Set-up/Update reporting to PMDA
• Vender Management (case volume assumption, contract, budget, account control, retention documents etc.)
• Enhancement of quality of vendor activity
• Management of internal process change
• Lead a significant taskforce team in PV

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