Job Title: Japan Local Case Advisor, GBS Patient Safety
Career Level - C

Introduction to role
Are you ready to make a difference in patient safety? As a Japan Local Case Advisor, you'll be at the heart of safety reporting for AstraZeneca and Rare Disease Unit products in Japan. This pivotal role involves managing Individual Case Safety Reports (ICSRs), ensuring compliance with Japanese regulatory requirements and AstraZeneca's pharmacovigilance standards. Based in Bangalore, you'll need proficiency in English and Japanese, and may work in Japan's time zone. You'll support the GBS PS function under the mentorship of Case Intake Team Managers, delivering routine activities independently and resolving moderate complexity problems. Are you up for the challenge?

Accountabilities
Case Intake (only for Japan domestic cases)
Accept, validate, and perform preliminary assessment of local safety cases, including phone calls with reporters
Handle personal information and confidential data per regulatory guidelines




Implement routine quality checks and undertake manual follow-up if required
Collaborate with internal partners to clarify or triage case information
Flag urgent or reportable cases for blocking issue resolution
Local Data Entry (applicable for both Japan domestic cases and Foreign cases)
Perform data entry into relevant safety database systems with high accuracy
Connect with internal collaborators to resolve data entry issues
Request follow-up information using specific product/event-related questionnaires
Audit / Inspection Readiness
Implement Corrective and Preventative Actions for local non-compliance
Follow SOPs for filing and archiving safety documentation
Support team in audits and regulatory authority inspections
Regulatory Compliance
Ensure adherence to Japanese regulatory standards for ICSRs and AE reporting
Call out urgent or high-risk cases following established procedures
Quality Management System (QMS)
Contribute to

📌 Japan Local Case Advisor, Gbs Patient Safety Bengaluru (India)
🏢 AstraZeneca
📍 India