Japan Local Case Advisor, Gbs Patient Safety

AstraZeneca

Bangalore, India
Japanese language proficiency n2 or higher
Individual case safety reports management
Data entry into safety database systems
This role involves managing Individual Case Safety Reports (ICSRs) to ensure compliance with Japanese regulatory requirements

Job Summary

  • This role involves managing Individual Case Safety Reports (ICSRs) to ensure compliance with Japanese regulatory requirements.
  • Candidates must possess strong Japanese language skills (N2 or higher) and proficiency in English to handle local case intake.
  • The position offers the opportunity to work within a dynamic team focused on patient safety and life-changing medicines.

Matching Summary

This role involves managing Individual Case Safety Reports (ICSRs) to ensure compliance with Japanese regulatory requirements.

Skills & Requirements

Must-have

  • Japanese language proficiency N2 or higher
  • Individual Case Safety Reports management
  • Data entry into safety database systems
  • Adherence to Japanese regulatory standards
  • High attention to detail for PII

Nice-to-have

  • Experience with ARGUS software
  • Knowledge of MedDRA and WHO-DD coding
  • Audit and inspection experience
  • Project management skills
  • Cross-functional collaboration abilities

Key Requirements

  • Degree qualified or equivalent experience
  • 1-2 years experience in local data entry
  • Life-science background preferred
  • Pharmacy, Medical, or Science degree desirable

Work Rights

Not specified

Tailored Resume

Cover Letter