Pharmacovigilance Sr Associate

Description

• 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

Qualifications

• 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