Group Purpose
Facilitate patient access to Amgen 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 Amgen 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 Amgen KK (Amgen Japan), 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 Amgen KK, 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, Amgen policies and procedures; and participating in exchange of safety information with stakeholders (Amgen, Amgen KK, 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 Amgen 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 Amgen KK and Amgen employees on safety reporting needs in Japan
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
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