Job Title: Japan Local Case Advisor – GBS Patient Safety
Location: Bangalore, India
Employment Type: Full-Time
Application Deadline: Open
Job Requisition ID: R-241346
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, the role requires proficiency in English and Japanese and may involve working in Japan’s time zone. Under the guidance of Case Intake Team Managers, you will independently perform routine safety reporting activities, address moderate complexity cases, and contribute to audits and regulatory compliance initiatives.
Case Intake (Japan Domestic Cases)
Accept, validate, and perform preliminary assessment of local safety cases.
Handle personal and confidential data in line with regulatory guidelines.
Implement routine quality checks and follow-up as needed.
Collaborate with internal partners to clarify or triage case information.
Escalate urgent or reportable cases for timely resolution.
Local Data Entry (Domestic & Foreign Cases)
Perform accurate data entry into safety database systems.
Resolve data entry issues in collaboration with internal stakeholders.
Request additional information using product/event-specific questionnaires.
Audit and Inspection Readiness
Implement Corrective and Preventive Actions (CAPAs) for local non-compliance.
Maintain proper filing and archiving of safety documentation.
Support team activities during audits and regulatory inspections.
Regulatory Compliance & Quality Management
Ensure compliance with Japanese regulatory standards for ICSRs and AE reporting.
Contribute to the effective implementation of Quality Management Systems (QMS).
Maintain up-to-date knowledge of product portfolio and local regulations.
Other Responsibilities
Conduct peer reviews and participate in ad-hoc projects.
Support pharmacovigilance aspects of Organised Data Collection Programmes.
Degree or equivalent experience in Life Sciences.
Japanese language proficiency: N2 or higher for listening, writing, and speaking; N3–N1 for reading Kanji, especially medical terminology.
English language proficiency: A2 (Waystage, CEFR).
1–2 years of experience in local data entry in safety databases.
High attention to detail and ability to handle personal/confidential information.
Strong problem-solving, collaboration, and communication skills.
Desirable Skills & Experience
Degree in Pharmacy, Medical, or Science.
Knowledge of pharmacovigilance principles and ARGUS safety database.
Familiarity with Good Pharmacovigilance Practice (GVP), Good Clinical Practice (GCP), and local regulations.
Experience in case intake, audit readiness, project management, or multinational team collaboration.
Knowledge of AE and drug coding conventions (MedDRA, WHO-DD).
At AstraZeneca, you will work in a dynamic, collaborative environment where your efforts directly impact patient safety and healthcare innovation globally. You will gain exposure to cutting-edge pharmacovigilance practices, build expertise in global safety standards, and grow your career while contributing to life-changing medicines.
Flexibility is balanced with in-person engagement, typically three days per week at the office, allowing you to thrive in a collaborative yet adaptable work environment.
How to Apply:
Submit your application to join AstraZeneca’s GBS Patient Safety team and contribute to transforming patient safety standards in Japan.
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