Pharmacovigilance Sr Associate

g 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

.