Job Title: Local Case Intake Advisor
Location: Bangalore, India
Employment Type: Full-time
GCL Level: C
Date Posted: 19-Sept-2025
Company Overview – AstraZeneca
AstraZeneca is a global biopharmaceutical company committed to life-changing medicines. The organization emphasizes collaboration, innovation, and digital advancements to enhance patient safety and care.
Work Culture: Minimum three days per week in-office with flexible arrangements
Focus: Cross-functional teamwork, regulatory compliance, and continuous skill development
Role Overview
The Local Case Intake Advisor plays a critical role in ensuring safety of AstraZeneca and Rare Disease Unit (RDU) products in Japan. Based in Bangalore, the role involves assessing, validating, and entering adverse events, including clinical trial data, in compliance with Japanese and global pharmacovigilance regulations.
Key Responsibilities
Accept, validate, and process safety cases for local case data entry (AstraZeneca and RDU products).
Perform data entry into safety database systems (e.g., ARGUS) with high accuracy.
Implement Corrective and Preventative Actions for non-compliance and complete late logs.
Reconcile pharmacovigilance data to ensure accuracy during transfer and receipt.
Conduct manual follow-up as needed to complete case reports.
Request follow-up information using product/event-specific questionnaires.
Identify and resolve discrepancies; initiate clarification requests when required.
Conduct in-line QC for clinical trial safety cases ensuring SOP and regulatory compliance.
Communicate with internal collaborators to resolve data entry issues or clarify cases.
Escalate urgent or high-risk cases following established procedures.
Adhere to standards for data entry in the Global Safety Database according to regulations.
Collaborate with Medical Information, Regulatory Affairs, and Quality teams to clarify or triage case information.
Follow SOPs for filing and archiving safety documentation for audit readiness.
Support responses to Health Authority (PMDA) queries and audits/inspections.
Maintain up-to-date knowledge of Japanese products, regulations, and safety reporting requirements.
Contribute to Quality Management System implementation for GvP compliance.
Perform peer review and other ad-hoc project-specific tasks as assigned.
Conduct literature searches and assess safety data if required.
Required Qualifications & Skills
Degree-qualified (life sciences background)
Language:
Japanese: JLPT N2 or higher (N3 possible with relevant data entry experience)
English: A2 Waystage (CEFR)
1–2 years experience in local data entry in a safety database
High attention to detail and confidentiality handling (PII)
Cross-functional collaboration, effective lateral thinking, problem-solving
Excellent written and verbal communication
Desirable Qualifications / Skills
Degree in Pharmacy / Medical / Science
Strong pharmacovigilance knowledge and local case intake experience
Familiarity with ARGUS
Understanding of Good Pharmacovigilance Practices (GVP) and Good Clinical Practice (GCP)
Experience with audits and inspections
Knowledge of AE and drug coding conventions (MedDRA, WHO-DD)
Project management and multinational team experience
Proficiency in standard office software (Word, Excel)
Diversity & Inclusion
AstraZeneca promotes diversity and equality, welcoming applications from all qualified candidates. Compliance with all relevant non-discrimination laws and work eligibility requirements is maintained.
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