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AstraZeneca, a global biopharmaceutical leader, is hiring a Local Case Intake Advisor for its Patient Safety / Pharmacovigilance operations in Bangalore, India. This full-time opportunity is ideal for professionals with experience in adverse event intake, ICSR processing, and pharmacovigilance compliance, who are comfortable working US shift hours.
In this role, you will play a critical part in protecting patient safety by ensuring accurate collection, processing, and reporting of safety data across clinical and post-marketing sources. The position offers exposure to global safety systems, regulatory interactions, audits, and GVP-compliant processes within a high-performing AstraZeneca team.
Key Responsibilities – Local Case Intake Advisor
- Manage local case intake processes for collection, reporting, and tracking of Adverse Events (AEs)
- Handle Individual Case Safety Reports (ICSRs) from clinical trials, post-marketing sources, literature, and organized data collection programs
- Review, assess, and process pharmacovigilance data in compliance with global and local SOPs
- Identify and triage Product Quality Complaints (PQC) and Product Security complaints
- Support responses to regulatory authority queries and internal/external collaborators
- Implement CAPA activities and manage late case processing logs
- Perform reconciliation of safety data to ensure accuracy and data integrity
- Conduct manual follow-ups using approved scripts and AstraZeneca resources
- Maintain audit-ready documentation and support inspections under GVP/GxP standards
- Complete mandatory patient safety trainings and maintain system access
Qualifications & Experience Required
Essential Skills
- Hands-on experience in pharmacovigilance / patient safety operations
- Strong understanding of AE intake, ICSR processing, and safety data workflows
- Knowledge of local regulatory requirements, global guidance documents, and Core Data Sheets
- Experience supporting audits, inspections, and compliance activities
- Strong documentation, reconciliation, and data quality skills
Desirable Skills
- Experience with Argus, ARISg, Veeva Vault Safety, or similar safety databases
- Background in clinical research, CROs, or pharmaceutical companies
- Degree in Life Sciences, Pharmacy, Nursing, or related discipline
- Knowledge of GVP, GxP, and real-world application
- Excellent English communication skills (additional languages are a plus)
Why Join AstraZeneca?
- Work with a global leader in patient safety and innovation
- Exposure to regulatory-facing pharmacovigilance activities
- Strong focus on digital transformation, AI, and data-driven safety operations
- Inclusive and diverse workplace culture
- Hybrid working model with flexibility (minimum 3 days in-office)
Salary & Job Details
- Location: Bangalore, Karnataka, India
- Employment Type: Full-time
- Shift: US Shift
- Career Level: C
- Estimated Salary: ₹8,00,000 – ₹14,00,000 per annum (based on experience and market standards)
How to Apply
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