Kimura Misae

Background

About Kimura Misae

promoted to Director, ISO Asia Group Lead GCS BRO Asia Team Leader(senior manager) Lead a team of BRO Asia colleagues to provide highly efficient and effective development, planning and management of investigational products and Supply Chain projects in support of our Business Unit (RU/BU) customers with end to end. Provide people leadership, supervision and coaching of 3-6 BRO Asia colleagues located in Japan and/or China Lead and/or contribute to strategic, innovative and continuous improvement initiatives. Support GCP inspection both PMDA and CFDI(China) as well as internal(RDS) Audit Clinical research Pharmacist Create and implement the Instruction for Administration Process for Patients and Develop and implement a training process for IP Handling for Clinical Site Personnel and Clinical Study Teams. 2014-2016 Secondment to US, Supply Chain Lead(Global SCL) Responsible for leading the development and execution of investigational material supply strategies for early and late stage development programs intended for regulatory approvals of new products and for new indications or line extensions of currently approved products. Working as a key member of the PharmSci Project Team, proactively recognize and address logistical and regulatory issues associated with the requirements of the clinical development program and project team objectives. Act as a subject matter expert on all information regarding the global use of investigational material in clinical studies. 2009 -2014 Supply Chain Lead(reginal SCL) Responsible for leading the development and execution of investigational material supply strategies for early and late stage development programs intended for regulatory approvals of new products and for new indications or line extensions of currently approved products. Working as a key member of the PharmSci Project Team, proactively recognize and address logistical and regulatory issues associated with the requirements of the clinical development program and project team objectives. Pharmacovigilance safety specialist(Wyeth KK) Lead and respond the GCP inspection by Authority and system inspection by Headquarter. 1998 - 2002 Pharmacovigilance safety specialist(Pharmacia Inc) 1995 - 1998 Supervisor Pharmacist :Consultation of how to use the drug for commercial product when the query received by medical or dentist 1990 - 1995 Dispending Pharmacist: Dispense the description drug and instruct how to take a medicine to the patients