Job Title: Japan Local Case Advisor – GBS Patient Safety
Location: Bangalore, India
Employment Type: Full-Time
Application Deadline: 18th December 2025
Job Requisition ID: R-241340
AstraZeneca is seeking a Japan Local Case Advisor to join its Global Business Services (GBS) Patient Safety team. This role is central to pharmacovigilance operations for AstraZeneca and Rare Disease Unit products in Japan. You will manage Individual Case Safety Reports (ICSRs), ensuring compliance with Japanese regulatory requirements and internal safety standards.
Based in Bangalore, this position requires proficiency in Japanese and English and may involve working in Japan’s time zone. Under the guidance of Case Intake Team Managers, you will perform routine safety reporting tasks independently, resolve moderately complex issues, and support audit and regulatory readiness initiatives.
Case Intake (Japan Domestic Cases)
Accept, validate, and perform preliminary assessment of local safety cases, including follow-up calls with reporters.
Handle confidential and personal information in compliance with regulatory guidelines.
Conduct routine quality checks and manual follow-ups when needed.
Collaborate with internal teams to clarify or triage case information.
Escalate urgent or reportable cases to ensure timely resolution.
Local Data Entry (Domestic & Foreign Cases)
Accurately enter data into safety databases and resolve discrepancies.
Request follow-up information using product/event-specific questionnaires.
Liaise with internal collaborators to resolve data entry issues.
Audit & Inspection Readiness
Implement Corrective and Preventive Actions (CAPAs) for local non-compliance.
Follow SOPs for proper filing and archiving of safety documentation.
Support audit and regulatory authority inspections.
Regulatory Compliance & Quality Management
Ensure adherence to Japanese regulatory standards for ICSRs and adverse event reporting.
Support effective operational implementation of the Quality Management System (QMS).
Maintain up-to-date knowledge of Japanese product portfolio and regulatory changes.
Additional Responsibilities
Conduct peer reviews and participate in ad-hoc projects.
Collaborate on pharmacovigilance aspects related to Organised Data Collection Programmes.
Degree in Life Sciences or equivalent experience.
Japanese proficiency: N2 or higher for listening, writing, and speaking; N3–N1 for reading Kanji in medical contexts.
English proficiency: A2 (Waystage, CEFR).
1–2 years of experience in local data entry within a safety database.
High attention to detail and ability to handle confidential information.
Strong problem-solving, collaboration, and communication skills.
Desirable Skills & Experience
Degree in Pharmacy, Medical, or Science.
Pharmacovigilance knowledge and experience with ARGUS.
Familiarity with Good Pharmacovigilance Practice (GVP), Good Clinical Practice (GCP), and relevant regulations.
Experience in local case intake, audits, project management, or multinational teams.
Understanding of AE and drug coding conventions (MedDRA, WHO-DD).
Join a dynamic and collaborative environment where your contributions directly impact patient safety and healthcare innovation. AstraZeneca offers exposure to cutting-edge pharmacovigilance practices, professional growth opportunities, and a culture of inclusion and innovation.
Flexibility is balanced with in-person engagement, typically three days per week at the office, enabling effective collaboration while maintaining individual adaptability.
How to Apply:
Submit your application by 18th December 2025 to become part of AstraZeneca’s GBS Patient Safety team and contribute to transforming patient safety standards in Japan.
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