Japan Local Case Advisor, GBS Patient Safety

Job Title: Japan Local Case Advisor, GBS Patient Safety

Career Level: C

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 ICSRs 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.

Ready to take the next step? Apply now and become part of our journey to transform patient safety!