Local Case Intake Advisor - Japanese Language

Astrazeneca India Private Limited; Bengaluru; On-site; INR 700,000 - 1,100,000; Full time

Job summary

AstraZeneca India Private Limited in Bengaluru is seeking an Associate - Local Case Intake Advisor (Japanese). You will manage local safety cases, validate reports, and ensure regulatory compliance under Japan requirements, using English and Japanese.

The role focuses on accurate data handling and cross-team collaboration. You will also perform data entry, quality checks, and support audits while working with global teams.

Qualifications

• Japanese proficiency required: N2+ listening/writing/speaking for Japan domestic cases; N3-N1 reading Kanji in medical terms.
• English proficiency: CEFR A2 level.
• Life-science background with 1–2 years local data entry in safety database.

Responsibilities

• Accept, validate, and preliminarily assess local safety cases, including calls from reporters.
• Perform data entry into safety databases with high accuracy and resolve data issues.
• Support audits and regulatory inspections; implement corrective actions as needed.

Skills

Japanese language proficiency

English language proficiency

Life-science background

Attention to detail

Cross functional collaboration

Education

Degree or equivalent

Pharmacy/Medical/Science degree

Tools

ARGUS

MS Office

Job description

Associate - Local Case Intake Advisor (Japanese Language) GCL: C2

Introduction to 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. Are you up for the challenge?

Accountabilities

Case Intake (only 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

Local Data Entry (applicable for both Japan domestic cases and Foreign cases)

• 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

Audit / Inspection Readiness

• 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

Regulatory Compliance

• Ensure adherence to Japanese regulatory standards for IC SARs and AE reporting
• Call out urgent or high-risk cases following established procedures

Quality Management System (QMS)

• Contribute to effective operational implementation of the QMS
• Maintain knowledge of Japanese product portfolio and regulation changes

General / Others

• Perform Peer review and ad-hoc project specific tasks as assigned
• Collaborate on PV aspects related to Organised Data Collection Programmes

Essential Skills/Experience

• Degree qualified or possessing equivalent experience
• Japanese language proficiency: N2 or higher for listening, writing and speaking (only for Japan domestic cases); N3-N1 for reading Japanese Kanji characters particularly in medical terminology
• 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 (PII)
• Cross functional collaborative approach
• Effective and lateral thinking
• Problem solving
• Excellent written and verbal communication skills

Desirable Skills/Experience

• 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 (Word, Excel)
• 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 (MedDRA, WHO-DD)
• Successful participation in above-market projects
• Audit & Inspection experience

When we put unexpected teams in the same room, we ignite daring thinking with the power to encourage life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our outstanding and ambitious world. AstraZeneca offers a dynamic environment where your contributions can lead to significant impacts on patients' lives. With a focus on innovation and collaboration, you'll be part of a team that demonstrates ground breaking technology to inspire change. Here, you'll find countless opportunities to grow your career while working alongside engaged colleagues who share your passion for making a difference.

Date Posted 09-Sept-2026 Closing Date 27-Sept-2026

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work is. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Experience Level Mid Level