Analyst - Local Case Intake Advisor (Japanese Language)

AstraZeneca — India - Bangalore

Job Title: Analyst - Local Case Intake Advisor (Japanese Language) GCL: 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 effective operational implementation o

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