Global biopharma leader GlaxoSmithKline (GSK) is currently hiring for the position of PV Ops Specialist I – ICSR Management in Bengaluru.
This pharmacovigilance job in Bengaluru is ideal for professionals with 2–6 years of experience in Individual Case Safety Report (ICSR) processing, pharmacovigilance systems, and regulatory compliance.
The role focuses on case processing, quality monitoring, KPI analysis, Argus configuration, and safety reporting compliance across clinical trials and marketed products.
For professionals seeking pharmacovigilance jobs in India, especially those experienced in ICSR management, Argus safety database, and regulatory reporting, this opportunity at GSK offers strong career growth in global drug safety operations.
Job Details
| Field | Details |
|---|---|
| Job Title | PV Ops Specialist I – ICSR Management |
| Company | GSK |
| Location | Bengaluru, India |
| Experience | 2–6 Years |
| Qualification | Life Sciences / Medical related degree |
| Job Type | Full-time |
| Application Deadline | March 20, 2026 |
Key Responsibilities – PV Ops Specialist (ICSR Management)
The PV Operations Specialist will support global pharmacovigilance operations with responsibilities including:
- Perform ICSR management monitoring checks and maintain proper documentation.
- Conduct KPI analysis for expedited reporting compliance and third-party reporting.
- Perform trend analysis for pharmacovigilance metrics and identify deviations.
- Investigate trends and conduct root cause analysis (RCA) using methods such as 5 Whys and Fishbone analysis.
- Develop Corrective and Preventive Actions (CAPA) for identified safety issues.
- Support case processing and coding conventions for Individual Case Safety Reports.
- Configure Argus Safety database for new clinical programs and submissions.
- Collaborate with Local Operating Companies (LOCs), CROs, and regulatory authorities.
- Ensure pharmacovigilance activities comply with global regulatory timelines and internal standards.
- Support audit and inspection readiness by maintaining documentation.
- Coordinate meetings, manage safety documentation repositories, and support departmental communication.
Required Qualifications
Candidates applying for this GSK pharmacovigilance job should have:
Education
- Degree in Life Sciences, Pharmacy, or related medical field
Experience
- 2–6 years of experience in pharmacovigilance
- Hands-on experience in ICSR case processing
Technical Skills
- Knowledge of ICSR submissions to health authorities
- Experience with Argus Safety database or PV systems
- Familiarity with pharmacovigilance regulatory requirements
- Knowledge of root cause analysis methodologies (5 Whys, Fishbone)
- Strong skills in process documentation and SOP authoring
Soft Skills
- Excellent organizational and communication skills
- Ability to work in cross-functional global teams
- Strong problem-solving and compliance mindset
Preferred Skills
GSK prefers candidates with:
- Experience in pharmacovigilance data management
- Knowledge of clinical trial safety reporting
- Familiarity with process improvement methodologies
- Experience working with vendors or CRO oversight
Salary and Benefits
Estimated salary for a PV Ops Specialist – ICSR Management in Bengaluru:
- ₹9,00,000 – ₹16,00,000 per year (approx.)
Benefits may include:
- Global career growth in pharmacovigilance
- Learning and development opportunities
- Exposure to clinical safety operations and regulatory compliance
- Collaborative global healthcare environment
Why Join GSK?
GlaxoSmithKline is one of the world’s leading biopharmaceutical companies, focused on advancing healthcare through innovation in:
- Vaccines
- Specialty medicines
- Infectious diseases
- Oncology
- Immunology
GSK aims to impact the health of 2.5 billion people globally while fostering a workplace culture built on patient focus, integrity, accountability, and collaboration.
How to Apply
