AstraZeneca is hiring a Japan Local Case Advisor – GBS Patient Safety for its Global Business Services (GBS) team in Bangalore, India. This is a highly specialized pharmacovigilance job focusing on Japanese local safety case management, regulatory compliance, and ICSR processing.
This opportunity is ideal for pharmacy, life science, and pharmacovigilance professionals with Japanese language proficiency who want to work on global drug safety operations supporting AstraZeneca and Rare Disease Unit products in Japan.
Job Overview
- Job Title: Japan Local Case Advisor, GBS Patient Safety
- Company: AstraZeneca
- Location: Bangalore, India
- Job Type: Full Time
- Work Model: Hybrid (minimum 3 days onsite)
- Experience Required: 1–2 years
- Language Requirement: Japanese (N2/N3/N1) & English
- Last Date to Apply: 29 December 2025
Key Responsibilities (Roles & Responsibilities)
Case Intake – Japan Domestic Cases
- Accept, validate, and preliminarily assess Individual Case Safety Reports (ICSRs)
- Communicate with reporters via phone and written correspondence
- Handle personal and confidential data in compliance with Japanese regulations
- Perform quality checks and manual follow-ups when required
- Identify and escalate urgent or reportable adverse event cases
Local Safety Data Entry
- Enter safety data accurately into validated pharmacovigilance databases
- Resolve data queries in collaboration with internal stakeholders
- Send follow-up questionnaires related to product and event information
Regulatory Compliance & Audit Readiness
- Ensure adherence to Japanese PV regulations and AstraZeneca SOPs
- Support internal and regulatory audits and inspections
- Implement Corrective and Preventive Actions (CAPA) for local non-compliance
Quality Management System (QMS)
- Support operational implementation of QMS
- Maintain up-to-date knowledge of Japanese product portfolios and PV regulations
Additional Responsibilities
- Peer review of safety cases
- Support Organised Data Collection Programmes
- Participate in ad-hoc and global pharmacovigilance projects
Eligibility & Qualifications
Essential Qualifications
- Degree in Life Sciences / Pharmacy / Science or equivalent experience
- Japanese Language Proficiency:
- N2 or higher (listening, writing, speaking)
- N3–N1 for reading medical Kanji
- English Proficiency: CEFR A2 or higher
- 1–2 years of experience in local safety data entry / pharmacovigilance
- Strong attention to detail and data privacy awareness
- Excellent communication and problem-solving skills
Desirable Skills
- Degree in Pharmacy, Medical, or Life Sciences
- Hands-on experience with ARGUS safety database
- Knowledge of GVP, GCP, MedDRA, WHO-DD coding
- Experience in local case intake and audit inspections
- Exposure to multinational or global PV teams
Salary & Benefits
- Estimated Salary: ₹8,00,000 – ₹14,00,000 per annum (based on experience & language proficiency)
- Work with a global biopharmaceutical leader
- Career growth in patient safety and pharmacovigilance
- Exposure to Japan regulatory environment
- Collaborative, inclusive, and innovation-driven workplace
Why Join AstraZeneca?
AstraZeneca offers a dynamic, inclusive environment where patient safety professionals directly contribute to life-changing medicines. Working in GBS Patient Safety gives you global exposure, regulatory depth, and long-term career growth in pharmacovigilance.
How to Apply
