Pharmacovigilance Associate - Japan Market

Why This Role Matters
The Japan Local Case Advisor role at AstraZeneca is critical in ensuring patient safety through accurate and timely pharmacovigilance activities. This role focuses on managing Individual Case Safety Reports (ICSRs) for the Japan market, one of the most regulated regions globally. By ensuring compliance with Japanese regulations and global PV standards, this position directly contributes to safeguarding patient health and maintaining regulatory trust. It also offers a unique opportunity to work in a niche, high-demand area combining pharmacovigilance expertise with Japanese language proficiency.

Job Description
As a Japan Local Case Advisor, you will be responsible for handling safety cases, performing data entry, ensuring regulatory compliance, and supporting audit readiness activities. The role involves working closely with global teams while focusing on Japan-specific pharmacovigilance requirements. You will manage case intake, follow-ups, and database activities while ensuring adherence to SOPs and quality standards.

Key Features of the Role:
Global pharmacovigilance exposure with Japan market specialization
Opportunity to work with multilingual and cross-functional teams
Strong career growth in Drug Safety and PV Operations
Hands-on experience with safety databases and compliance systems
Hybrid work environment with international collaboration

Responsibilities

• Accept, validate, and perform preliminary assessment of safety cases (Japan domestic)
• Conduct follow-ups with reporters, including phone-based communication
• Ensure proper handling of confidential and personal data as per regulations
• Perform accurate data entry into safety databases for domestic and foreign cases
• Collaborate with internal teams to resolve case-related queries and discrepancies
• Request follow-up information using product/event-specific questionnaires
• Flag urgent or high-risk cases for immediate action

• Support audit and inspection readiness activities
• Implement CAPA for compliance gaps and deviations
• Maintain proper documentation, filing, and archiving as per SOPs

• Ensure compliance with Japanese regulatory requirements for AE reporting
• Identify and escalate critical safety cases as per defined procedures

• Contribute to Quality Management System (QMS) implementation
• Maintain updated knowledge of Japanese regulations and product portfolio

• Perform peer review and support project-specific tasks
• Collaborate on pharmacovigilance activities for organized data programs

Required Qualifications
Candidates should have a life sciences background along with strong pharmacovigilance fundamentals and Japanese language proficiency.

Educational Requirements:
Life Sciences (B.Pharm, M.Pharm, MSc, PharmD) or equivalent

Experience and Skills:
• 1–2 years of experience in pharmacovigilance or safety database handling
• Experience in ICSR data entry and case processing
• Japanese language proficiency (N2 or higher preferred; N3 acceptable for some tasks)
• English proficiency (basic to intermediate level)
• Strong attention to detail and data accuracy
• Knowledge of pharmacovigilance workflows and AE reporting

Technical & Preferred Skills:
• Experience with safety databases such as ARGUS
• Knowledge of MedDRA and WHO-DD coding
• Understanding of GVP, GCP, and regulatory requirements
• Experience in case intake and follow-up processes
• Familiarity with audits and inspection readiness
• Strong communication and cross-functional collaboration skills

Salary Insights:
Estimated Salary Range: ₹6 LPA – ₹12 LPA
Salary depends on experience, Japanese language proficiency, and PV expertise

Company Overview
AstraZeneca is a leading global biopharmaceutical company focused on the discovery, development, and commercialization of prescription medicines. With a strong presence in oncology, cardiovascular, renal, and rare diseases, AstraZeneca is known for its innovation-driven approach and commitment to patient safety. The company offers a collaborative work environment with opportunities to work on global projects and cutting-edge healthcare solutions.

FAQs

What makes this role unique?
This role combines pharmacovigilance with Japanese language expertise, making it highly specialized and in demand.

Is Japanese language mandatory?
Yes, proficiency in Japanese (N2/N3 level) is essential for handling Japan-specific cases.

What is the main responsibility?
Handling ICSRs, performing case intake, and ensuring compliance with Japanese PV regulations.

What tools will I use?
Safety databases like ARGUS and coding dictionaries such as MedDRA and WHO-DD.

What career growth can I expect?
You can grow into Senior PV Specialist, Drug Safety Scientist, or PV Project Manager roles.

Application Tips
Highlight your Japanese language certification (JLPT level) clearly
Emphasize ICSR processing and pharmacovigilance experience
Mention experience with safety databases like ARGUS
Showcase your understanding of global and Japanese PV regulations
Prepare for scenario-based questions on case processing and compliance