Japan Local Case Advisor, Gbs Patient Safety

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Bangalore, India
Japanese language proficiency n2 or higher
Individual case safety reports management
Astrazeneca pharmacovigilance standards compliance
This role involves managing Individual Case Safety Reports for AstraZeneca products while ensuring strict adherence to Japanese regulatory requirements

Job Summary

  • This role involves managing Individual Case Safety Reports for AstraZeneca products while ensuring strict adherence to Japanese regulatory requirements.
  • Candidates must possess high attention to detail to validate local safety cases and handle confidential personal information per regulatory guidelines.
  • The position offers a dynamic environment where contributions lead to significant impacts on patients' lives within a team focused on innovation.

Matching Summary

This role involves managing Individual Case Safety Reports for AstraZeneca products while ensuring strict adherence to Japanese regulatory requirements.

Skills & Requirements

Must-have

  • Japanese language proficiency N2 or higher
  • Individual Case Safety Reports management
  • AstraZeneca pharmacovigilance standards compliance
  • Local data entry in safety database systems
  • Life-science background with 1-2 years experience

Nice-to-have

  • Experience with ARGUS software
  • Knowledge of MedDRA and WHO-DD coding
  • Audit and inspection readiness support
  • Cross-functional collaborative approach
  • Project management capabilities

Key Requirements

  • Degree qualified or equivalent experience
  • Japanese language proficiency N2 listening/writing/speaking
  • English language proficiency A2 Waystage based on CEFR
  • 1–2 years of experience in local data entry
  • Medical terminology reading capability (N3-N1 Kanji)

Work Rights

Not specified

Tailored Resume

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