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 Valuable 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

📌 Japan Local Case Advisor, Gbs Patient Safety (Karnataka)
🏢 AstraZeneca
📍 Karnataka