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GlaxoSmithKline (GSK), a global biopharmaceutical leader, is hiring a Senior Specialist – ICSR Management for its Bengaluru (Luxor North Tower) location. This full-time pharmacovigilance role is ideal for professionals with strong expertise in Individual Case Safety Report (ICSR) processing, Argus configuration, clinical trial safety, and global regulatory reporting.
As part of GSK’s PV Operations team, you will play a critical role in ensuring high-quality safety data management across the lifecycle of clinical trials and marketed products, while working in a complex global matrix environment.
Job Overview
- Job Title: Senior Specialist – ICSR Management
- Job Requisition ID: 432438
- Location: Bengaluru, Karnataka
- Employment Type: Full Time
- Last Date to Apply: 2 January 2026
- Company: GlaxoSmithKline (GSK)
Key Responsibilities
As a Senior Specialist – ICSR Management at GSK, your responsibilities will include:
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- End-to-end ICSR case handling, from receipt to expedited regulatory reporting
- Ensuring compliance with GVP, GCP, CTR, and global pharmacovigilance regulations
- Collaboration with SERM teams, Local Operating Companies (LOCs), CROs, and Clinical Operations
- Oversight of Argus Safety Database configuration for clinical and post-marketing programs
- Supporting study start-up, maintenance, and close-out activities, including protocol and SMP reviews
- Monitoring KPIs, identifying risks, and driving CAPA implementation
- Vendor and third-party oversight to ensure robust PV processes
- Managing PV Operations mailboxes for spontaneous and clinical safety queries
- Providing guidance and mentoring to Technical Associates on ICSR processes
Required Qualifications & Skills
Educational Background
- Degree in Pharmacy, Life Sciences, Medicine, or related discipline
Experience & Technical Skills
- Proven experience in ICSR Management and Case Processing
- Strong working knowledge of Argus Safety Database
- Hands-on experience with clinical trial safety reporting
- Understanding of global regulatory requirements and reporting timelines
- Knowledge of medical terminology and safety coding conventions
- Experience with vendor oversight and reconciliation activities
Experience Needed
- Minimum: 5–7 years of relevant experience in Pharmacovigilance / Clinical Safety
- Preferred:7–10 years for candidates handling:
- End-to-end ICSR processing
- Argus Safety Database configuration
- Clinical trial safety reporting
- Vendor and CRO oversight
- Global regulatory submissions (US FDA, EMA, MHRA, etc.)
Soft Skills
- Strong communication and stakeholder management skills
- Excellent prioritization and time-management abilities
- Analytical mindset with attention to detail
Why Join GSK?
- Work with a world-leading biopharma organization
- Global exposure to clinical and post-marketing pharmacovigilance
- Strong focus on innovation, ethics, and patient safety
- Inclusive workplace culture with career growth opportunities
- Opportunity to contribute to medicines and vaccines impacting billions of lives worldwide
How to Apply
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