GlaxoSmithKline (GSK), a global biopharmaceutical leader, is hiring a Senior Specialist – ICSR Management for its Pharmacovigilance Operations team in Bengaluru. This role is ideal for experienced pharmacovigilance professionals with strong expertise in ICSR processing, Argus safety database configuration, vendor oversight, and global regulatory reporting.
At GSK, you will work in a highly collaborative global environment, supporting clinical trials and marketed products while ensuring compliance with GVP, GCP, CTR, and worldwide regulatory requirements. If you are looking for senior-level drug safety and pharmacovigilance jobs in India, this is a high-impact opportunity.
🧪 Job Role: Senior Specialist – ICSR Management
📍 Location
Bengaluru – Luxor North Tower
🕒 Employment Type
Full Time
⏳ Last Date to Apply
29 January 2026
🧾 Key Responsibilities – Pharmacovigilance & ICSR Management
- End-to-end ICSR case handling from receipt to expedited reporting
- Ensure compliance with global pharmacovigilance regulations (GVP, GCP, CTR)
- Perform Argus safety database configuration for new studies and programs
- Support clinical trial safety set-up, maintenance, and close-out activities
- Collaborate with SERM, LOCs, CROs, and Clinical Operations teams
- Review Safety Management Plans (SMP), DMPs, PDEGs, and study documents
- Conduct spot checks in JIRA and safety repositories
- Oversee vendor performance, training materials, and KPIs
- Manage PV Operations mailboxes for clinical and spontaneous reports
- Identify issues, perform root cause analysis, and implement CAPAs
- Support ICSR Management Leads with reconciliation and oversight activities
🎓 Required Qualifications & Skills
- Degree in Pharmacy, Life Sciences, Medicine, or related field
- Strong knowledge of pharmacovigilance methodology and ICSR processing
- Hands-on experience with Argus Safety Database (highly preferred)
- In-depth understanding of medical terminology and adverse event reporting
- Experience working with CROs, vendors, and global stakeholders
- Familiarity with regulatory submissions and global reporting timelines
- Excellent communication, prioritization, and time management skills
💼 Why Work at GSK?
- Work with a top global biopharma company
- Exposure to global clinical trials and safety operations
- Strong focus on innovation, compliance, and patient safety
- Inclusive workplace with career growth opportunities
- Competitive compensation and benefits
💰 Salary (Estimated)
₹12,00,000 – ₹20,00,000 per annum
(Based on experience, skills, and industry standards in India)
📝 How to Apply?
