メディカル・バイオ - 安全性情報（臨床開発・製販後GVP）

【Job Description】
■Group Purpose
Facilitate patient access to The company products in Japan through the following: compliance with applicable local regulations; development and maintenance of local business processes in pharmacovigilance (PV) and post marketing surveillance (PMS), integrated in relevant The company processes; development and execution of Japan risk management plan (J-RMP); assessment of safety data in Japan; provision of safety expertise; leading and collaborating on post marketing surveillance (PMS) activities; interface with regulatory agencies and industry organization; alignment with key cross-functional partners and business partners; continuous improvement of business processes

【Job Summary】
As part of the Japan Safety organization at The company, the Japan Safety PV Sr Assoc is responsible for: performing PV activities under the guidance of Japan Safety PV Sr Manager, Japan Safety PV Team Manager, or Japan Safety PV Manager: contributing to the local safety function in interactions with other functions within The company, staff members in Global Patient Safety, business partners and external health care professionals, to achieve Safety objectives; helping ensure compliant and efficient performance of local safety activities based on sound knowledge of local legislative requirements and practice, The company policies and procedures; and participating in exchange of safety information with stakeholders (The company, partners, and external; local, regional, and global) to support informed understanding of product safety issues.

This position reports to Japan Safety PV Sr Mgr, Japan Safety PV Manager, or Japan Safety PV Manager

【Key Activities】
Perform the following tasks, under the direction and guidance of the Japan Safety PV Sr Mgr, Japan Safety PV Team Manager, and/or Japan Safety PV Mgr: 

■General:
Execute safety (PV) processes for The company's products 
Represent the Safety function on local product team(s) and joint product team(s) and Joint product teams(s) 
Ensure safety compliance review and quality of safety part of CTN and NDA dossiers in Japan 
Contribute to the creation and improvement of local business processes and system infrastructure for safety information collection and management 

■Safety Reporting and Safety Database:
Contribute to Safety Database conventions development and maintain current awareness of those conventions
Prepare the local periodic aggregate safety reports (e.g., J-DSUR, J-PBRER)
Perform assigned tasks ICSR handling workflow and the preparation of Japan-specific safety reports 

■Risk management and Risk communication: 
Collaborate with cross-functional stakeholders on risk management planning and local risk minimization actions 

■Compliance and Regulatory:
Advocate safety compliance 
Prepare for and participate in regulatory inspections by Regulatory Authorities  

■Training and Other Cross-functional Activities:
Train The company(in Japan) and The company employees on safety reporting needs in Japan 

■休日：完全週休二日制, 祝日, GW, 夏季休暇, 年末年始

■Knowledge and Skills
Experience in directly related to safety areas including PV regulations
English language proficiency (business discussions, reading, and writing)
General understanding of industry practices and standards 
Experience with MS Word, Excel, PowerPoint, and Outlook

■Education & Experience (Basic)
Not applicable for positions in Japan 

■Education & Experience (Preferred)
Master’s degree and 1 year of directly related experience 
OR 
Bachelor’s degree and 3 years of directly related experience

■職種未経験者：不可