Tóm tắt công việc
Nghề | Nghề yêu cầu chuyên môn (Tư vấn, Tài chính, Bất động sản, Dịch vụ chuyên môn)/Dịch vụ chuyên môn (y tế, phúc lợi xã hội, giáo dục, hướng dẫn viên) |
---|---|
Ngành | Y tế/ Các ngành y tế khác |
Hình thái tuyển dụng | Chưa phân loại |
Chức vụ | Khác |
Số lượng tuyển dụng | 1 người |
Ngày muốn vào làm | - |
Kỹ năng ngôn ngữ cần thiết |
Tiếng Anh (Giao tiếp kinh doanh) Tiếng Nhật (Thành thạo) |
Ngôn ngữ có thể sử dụng | - |
Thời gian làm việc | Khác |
Ngày nghỉ / Phúc lợi y tế | |
Hỗ trợ xin visa | - |
Nhân viên người nước ngoài | - |
Chi tiết công việc
Company Overview
Pharmaceuticals Company
Job Description
• Planning and conducting PMS activities for Medical products
• Manage the relationship with Pharmacovigilance providers and internal personnel
• Contribute to the development, production, and maintenance of the appropriate tracking and compliance tools, reports, plans, tasks and activities pertaining to the management of the pharmacovigilance activities
• Support and/or draft regulatory inquiry responses related to pharmacovigilance/safety issues to regulatory agencies, EC/IRB, Investigators, and ad hoc inquiries
• Provide input and review to key regulatory or clinical documents (i.e., clinical study reports, investigator brochures, integrated summaries of safety, DSUR, etc.) related to pharmacovigilance
• Participate in internal global pharmacovigilance meetings as well as joint safety meetings with partners if needed
Requirements
• Minimum five (5) years in PMS in pharmaceutical industries setting with both investigational and marketed products
• Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments (including ICH/CIOMS, Clinical development methodology and knowledge of Clinical Trial guidelines (GCP) and regulation) is essential
• Practical examples of end-to-end project management within Drug Safety/PV or relevant experience
• Active participation in regulatory inspections is a plus
• At least two (2) years of experience with, aggregate safety reporting, safety surveillance, signal management and/or Risk management
Về cuộc phỏng vấn
Địa chỉ liên lạc
PMS Manager
RGF HR Agent
1000 〜 1300 ten thousand JPY