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"Career Opportunity at GSK India – Senior Specialist, ICSR Management"
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"GSK Hiring Senior Specialist – ICSR Management in Bengaluru | Pharmacovigilance Jobs India"
GlaxoSmithKline (GSK), a global leader in biopharma, is inviting applications for the role of Senior Specialist – ICSR Management at its Bengaluru office. This opportunity is ideal for experienced professionals in pharmacovigilance, drug safety, and clinical research operations who want to contribute to GSK’s mission of improving the health of 2.5 billion people worldwide.
If you have expertise in ICSR processing, case management, and regulatory safety reporting, this could be the right career move for you.
Key Responsibilities:-
As a Senior Specialist – ICSR Management at GSK, you will:
- Manage end-to-end case processing – from receipt to expedited reporting.
- Collaborate with SERM, CROs, LOCs, and clinical teams to ensure compliance.
- Oversee vendor performance, track KPIs, and manage CAPA (Corrective and Preventive Actions).
- Support study/program setup, review safety protocols, and ensure reconciliation activities.
- Assist in Argus safety database configuration for regulatory submissions.
- Participate in UAT reviews, vendor training, and compliance monitoring.
- Stay updated on global regulations (ICH GCP, GVP, CTR).
- Mentor junior associates in ICSR processes and case handling.
Qualifications & Skills Required:-
To qualify for this role, candidates should have:
- Strong understanding of Good Pharmacovigilance Practice (GVP), Good Clinical Practice (GCP), and Clinical Trial Regulations (CTR).
- Proven expertise in ICSR processing and safety databases (Argus preferred).
- Knowledge of medical terminology and case coding conventions.
- Experience in vendor oversight, KPI monitoring, and process improvement.
- Excellent communication, time management, and prioritization skills.
Why Join GSK?
Working at GSK offers a unique opportunity to:
- Be part of a purpose-driven global organization.
- Gain exposure to international pharmacovigilance operations.
- Access career growth opportunities and professional development programs.
- Work in a collaborative and innovative environment focused on patient safety.
How to Apply:-
Interested candidates can apply directly through the official GSK careers portal:
👉 Apply Here
FAQs:-
Q1: What is the location of this job?
This role is based at GSK’s Bengaluru, India office.
Q2: What experience is required for the Senior Specialist role?
Candidates should have strong experience in ICSR processing, pharmacovigilance operations, and safety database management (preferably Argus).
Q3: Is vendor management experience necessary?
Yes, the role involves vendor oversight, KPI monitoring, and escalation management.
👉 This is a great opportunity for professionals in pharmacovigilance and drug safety who want to advance their careers with one of the world’s leading biopharma companies.
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