Japan Local Case Advisor, GBS Patient Safety at AstraZeneca

Bengaluru, karnataka, India -

Full Time

Start Date

Immediate

Expiry Date

19 Jul, 26

Salary

0.0

Posted On

20 Apr, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacovigilance, Case intake, Data entry, Regulatory compliance, Japanese language, English language, Medical terminology, Attention to detail, Problem solving, Communication skills, Quality management system, Audit readiness, Safety reporting, Cross-functional collaboration, MedDRA, WHO-DD

Industry

Pharmaceutical Manufacturing

Description

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! Date Posted 19-Apr-2026 Closing Date 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 will be. 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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Responsibilities

Manage Individual Case Safety Reports (ICSRs) and perform local data entry while ensuring compliance with Japanese regulatory standards. Collaborate with internal teams to resolve case information issues and support audit and inspection readiness.