Japan Local Case Advisor – GBS Patient Safety | AstraZeneca India
Job ID: R-241353
Posted Date: January 06, 2026
Contract Type: Full-Time
Location: Bangalore, India (Japan Time Zone alignment required)
Company Overview
AstraZeneca is a global, science-led biopharmaceutical company committed to delivering innovative medicines that transform patient outcomes. With over 45 years of presence in India, AstraZeneca continues to provide sustainable, affordable, and groundbreaking healthcare solutions.
As a member of AstraZeneca’s Global Business Services (GBS) Patient Safety function, you will play a critical role in ensuring patient safety through meticulous safety reporting, compliance, and high-quality pharmacovigilance practices.
Role Summary
The Japan Local Case Advisor will be responsible for managing Individual Case Safety Reports (ICSRs) for AstraZeneca and Rare Disease Unit products in Japan. This role requires proficiency in Japanese and English, and an ability to operate within Japan’s regulatory and time zone requirements. Reporting to Case Intake Team Managers, you will independently handle routine safety activities and moderate-complexity cases while contributing to audit readiness and regulatory compliance.
Key Responsibilities
Case Intake (Japan Domestic Cases)
Receive, validate, and perform preliminary assessment of local safety cases.
Communicate with reporters via phone calls to clarify case information.
Ensure confidentiality and proper handling of personal information according to regulatory standards.
Conduct quality checks and manual follow-ups when required.
Flag urgent or reportable cases for escalation and resolution.
Local Data Entry (Domestic and Foreign Cases)
Accurately enter safety data into relevant databases.
Collaborate with internal teams to resolve data entry discrepancies.
Request additional information using product- or event-specific questionnaires.
Audit & Inspection Readiness
Implement corrective and preventive actions for non-compliance.
Follow SOPs for filing, archiving, and maintaining safety documentation.
Support audits and regulatory inspections as required.
Regulatory Compliance & Quality Management
Ensure compliance with Japanese regulatory requirements for ICSRs and adverse event reporting.
Maintain awareness of changes in Japanese regulations and AstraZeneca product portfolios.
Contribute to operational implementation of the Quality Management System (QMS).
General Responsibilities
Participate in peer review and project-specific tasks.
Collaborate on pharmacovigilance activities related to organized data collection programs.
Required Skills & Experience
Bachelor’s degree or equivalent experience in Life Sciences, Pharmacy, Medical, or Science-related fields.
Japanese Language: N2 or higher for speaking, listening, and writing; N3–N1 for reading medical Kanji characters.
English Language: Minimum A2 (Waystage) CEFR proficiency.
1–2 years of experience in local safety data entry or pharmacovigilance operations.
Strong attention to detail with the ability to handle confidential information.
Cross-functional collaboration and effective problem-solving skills.
Excellent verbal and written communication skills.
Preferred Skills & Experience
Experience in pharmacovigilance with knowledge of ICSR handling.
Familiarity with ARGUS safety database and case intake processes.
Knowledge of Good Pharmacovigilance Practice (GVP), Good Clinical Practice (GCP), and relevant regulatory guidelines.
Experience in audits, inspections, and multinational team collaboration.
Understanding of AE and drug coding conventions (MedDRA, WHO-DD).
Basic proficiency in MS Office (Word, Excel) and project management capabilities.
Why Join AstraZeneca
Contribute to patient safety and life-changing medicines through high-quality pharmacovigilance operations.
Collaborate with global teams in a dynamic, innovative, and regulatory-compliant environment.
Access opportunities for career growth, skill development, and exposure to international best practices in pharmacovigilance.
Work in a culture that values diversity, inclusion, and innovation, with flexible working arrangements while maintaining in-office collaboration.
Application Deadline: January 29, 2026
AstraZeneca India is an equal opportunity employer. We welcome applications from qualified candidates of all backgrounds and comply with applicable laws on non-discrimination and work eligibility.
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