Local Case Intake Advisor | Bangalore, India
Company: AstraZeneca India | Job Type: Full-Time | Contract: Permanent | Job ID: R-235797
About AstraZeneca India
For over 45 years, AstraZeneca has been at the forefront of delivering life-changing medicines across India. We are committed to innovative, sustainable, and accessible healthcare. Our teams leverage cutting-edge technology, collaboration, and scientific expertise to transform patient outcomes and drive global healthcare solutions.
As a Local Case Intake Advisor, you will contribute directly to pharmacovigilance and patient safety, ensuring compliance with local and global regulations while working with a multinational team.
Role Overview
The Local Case Intake Advisor plays a critical role in managing foreign case intake activities for Japan safety reporting. Based in Bangalore, you will work in alignment with the Japan time zone and holiday calendar, applying your Japanese language skills to assess, validate, and accurately enter adverse events. This role offers an opportunity to work independently, solve complex problems, and collaborate with cross-functional teams to maintain AstraZeneca’s high standards for safety and compliance.
Key Responsibilities
Accept, validate, and process safety cases for AstraZeneca and Rare Disease Unit products.
Enter and maintain high-quality data in safety databases (e.g., ARGUS) in compliance with regulatory standards.
Perform reconciliations to ensure data accuracy for pharmacovigilance reporting.
Identify discrepancies, request clarifications, and escalate high-risk or urgent cases.
Communicate effectively with internal collaborators to clarify case content and resolve data issues.
Follow SOPs for filing and archiving safety documentation to ensure audit readiness.
Support responses to Health Authority queries (PMDA) as needed.
Maintain up-to-date knowledge of Japanese product regulations, global pharmacovigilance guidance, and Good Pharmacovigilance Practices (GVP).
Perform peer reviews and ad-hoc tasks as required.
Conduct literature searches and support safety case evaluation for AZ product portfolio.
Essential Qualifications & Skills
Degree-qualified in Pharmacy, Medical, or Life Sciences
Japanese language proficiency: JLPT N3 or higher (or 1–2 years of experience in global safety databases)
English proficiency (CEFR A2 Waystage minimum)
1–2 years of experience in clinical trial case handling or pharmacovigilance data entry
Life-science background with knowledge of adverse event reporting
Strong problem-solving, lateral thinking, and collaborative skills
Excellent written and verbal communication
Desirable Qualifications
Experience with ARGUS or other pharmacovigilance databases
Familiarity with MedDRA/WHO-DD coding, GVP/GCP, and Health Authority regulations
Audit or inspection experience
Participation in cross-market or global pharmacovigilance projects
Why Join AstraZeneca?
Opportunity to work in a multinational, patient-focused organization
Hands-on experience in pharmacovigilance and regulatory compliance
Dynamic, collaborative, and innovative work culture
Exposure to cutting-edge technology and global healthcare projects
Flexible work arrangements with a minimum of 3 days in-office per week
Diversity & Inclusion
AstraZeneca is committed to building an inclusive and diverse team, representing all backgrounds and perspectives. We encourage applications from all qualified candidates and comply with all applicable employment laws.
Gujarat :
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Japan | Saitama |Tokyo :
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