CW- Global Safety Admin (파견직 2개월)

CW- Global Safety Admin (파견직 2개월)
South Korea - Seoul Apply Now
JOB ID: R-214212
LOCATION:
South Korea - Seoul
WORK LOCATION TYPE:
Flex Commuter / Hybrid
DATE POSTED: May. 07, 2025
CATEGORY: Safety
Key Activities
Local Safety Affiliate Activities (For local country or countries):
- Maintains own current knowledge of and compliance with local safety regulations for local country or countries
- Ensures that local safety activities are documented and filed or archived in line with Amgen /GPS policies and procedures
- Assists local Safety team with preparations for audits & inspections of safety operations
- Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
Core Safety Affiliate Responsibilities:
- Performs timely & accurate local processing steps for all adverse events reported to the local affiliate, from all sources, to enable entry into the Global Safety Database
- Support to submit ICSRs to local regulatory authority on time
Compliance Activities:
- Works with Safety Country Lead to maintain required standard of local operating performance and reporting compliance for AE cases
Knowledge and Skills
- Understanding and compliance with procedures and regulations relevant to assigned responsibilities
- Computer literacy with some knowledge of database use
- Awareness of local data privacy requirements
- Understanding of relevant medical & safety terminology
- Skilled in translating English simple medical documents into Korean
Education & Experience (Preferred)
- Degree in Nursing (Associate’s or Bachelor’s) preferred