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Associate - Local Case Intake Advisor (Japanese Language)AstraZeneca · India - Bangalore

AstraZeneca

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Associate - Local Case Intake Advisor (Japanese Language)

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🗓️ Posted 2026-09-10 India - Bangalore Full-time Hybrid Healthcare Medical

💰 Salary Not shared 📊 Market ₹60,000–₹100,000/mo (₹720,000–₹1,200,000/yr)

About the Company

We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com. Community Guidelines: bit.ly/2MgAcio Pharmaceutical Manufacturing Specialties: Pharmaceutical, Biopharmaceutical, Innovation, Research and development, Global business

About the 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.

Responsibilities

● Case Intake 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
● 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
● 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
● Ensure adherence to Japanese regulatory standards for ICSRs and AE reporting
● Call out urgent or high-risk cases following established procedures
● Contribute to effective operational implementation of the Quality Management System
● Maintain knowledge of Japanese product portfolio and regulation changes
● Perform Peer review and ad-hoc project specific tasks as assigned
● Collaborate on PV aspects related to Organised Data Collection Programmes

Requirements

● Degree qualified or possessing equivalent experience
● Japanese language proficiency: N2 or higher for listening, writing and speaking
● English language proficiency: A2 Waystage based on CEFR
● Life-science background
● 1-2 years of experience in local data entry in a safety database
● High attention to detail and ability to identify personal/confidential information
● Cross functional collaborative approach
● Effective and lateral thinking
● Problem solving
● Excellent written and verbal communication skills

Nice to Have

● Degree qualified in Pharmacy, Medical, or Science, or with equivalent experience
● Pharmacovigilance knowledge excellence
● Experience with ARGUS
● Experience in local case intake
● Familiarity with Good Pharmacovigilance Practice / Good Clinical Practice and relevant regulations
● Influencing, and Conflict Resolution skills
● Basic knowledge of standard office software packages
● Experience working with multinational teams
● Medical knowledge in company Therapeutic Areas
● Project management
● Ability to quickly develop good understanding of AE and drug coding conventions
● Successful participation in above-market projects
● Audit & Inspection experience