Local Case Intake Advisor – Bangalore, India
Company: AstraZeneca
Location: Bangalore, India
Employment Type: Full-Time
Experience Required: 1–3 Years
Application Deadline: 31st December 2025
Job Overview
AstraZeneca is seeking a Local Case Intake Advisor to join our Patient Safety and Pharmacovigilance team in Bangalore. This role is critical to ensuring patient safety by accurately capturing, processing, and communicating adverse event (AE) information in compliance with global and local regulations. The ideal candidate is detail-oriented, digitally proficient, and experienced in pharmacovigilance operations within a pharmaceutical or clinical research environment.
The Local Case Intake Advisor will work US shift hours and collaborate with internal and external stakeholders to maintain high-quality safety data, uphold regulatory compliance, and support operational excellence.
Key Responsibilities
Case Intake & Data Management
Collect, review, and process Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing sources, ensuring compliance with SOPs and local regulations.
Identify and triage Product Quality Complaints (PQC) and Product Security Complaints, gathering all necessary data for AE reporting.
Maintain safety data accuracy and reconciliation, supporting audits, inspections, and data integrity initiatives.
Regulatory & Stakeholder Support
Provide timely and compliant responses to queries from regulatory authorities, internal teams, and external collaborators.
Implement Corrective and Preventive Actions (CAPA) for local non-compliance and ensure proper handling of late logs.
Support Good Pharmacovigilance Practice (GVP) through documentation, process adherence, and audit readiness.
Follow-up & Documentation
Conduct manual follow-ups with patients using approved scripts to ensure accurate reporting.
Archive and maintain patient safety documentation to meet inspection readiness standards.
Maintain up-to-date knowledge of local regulations, product status, core data sheets, and safety obligations.
Essential Qualifications & Skills
Degree: Life Sciences, Pharmacy, Nursing, or equivalent.
Experience: 1–3 years in pharmacovigilance, patient safety, or clinical research operations.
Knowledge of GxP, GVP, and regulatory compliance frameworks.
Familiarity with safety databases and commercial systems such as Argus, ARISg, or Veeva Vault Safety.
Strong analytical, documentation, and data reconciliation skills.
Excellent verbal and written communication in English and local language; additional languages advantageous.
Ability to work independently in a fast-paced, cross-functional environment.
Desirable Attributes
Experience in global safety operations, AE case processing, and regulatory reporting.
Strong interpersonal skills and the ability to liaise with clinical, regulatory, and commercial teams.
Detail-oriented with a focus on data integrity and audit readiness.
Why AstraZeneca?
AstraZeneca combines cutting-edge science with digital innovation to deliver life-changing medicines globally. We foster an inclusive and diverse environment where curiosity, collaboration, and accountability drive patient-centered outcomes. Employees enjoy exposure to global pharmacovigilance practices, advanced data systems, and opportunities to contribute meaningfully to patient safety.
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