GlaxoSmithKline (GSK), a global biopharma leader, is inviting applications for the position of Senior Specialist, ICSR Management at its Bengaluru office. This role offers an excellent chance to work at the forefront of pharmacovigilance, ICSR processing, case management, and regulatory safety reporting while contributing to GSK’s mission of improving health for 2.5 billion people worldwide.
If you’re an experienced professional in drug safety, clinical research, or pharmacovigilance operations, this position could be your next career milestone.
Key Responsibilities
As a Senior Specialist, ICSR Management, you will:
- Handle end-to-end case management activities – from case receipt to expedited reporting.
- Collaborate with SERM, LOCs, CROs, and clinical operations teams to ensure safety data compliance.
- Manage vendor oversight, monitor KPIs, and escalate issues for CAPA implementation.
- Assist with study/program setup, review protocols, SMPs, DMPs, PDEGs, and reconciliation activities.
- Support Argus configuration for safety database submissions to regulatory authorities, partners, and LOCs.
- Review UAT outputs, oversee vendor training, and ensure regulatory compliance.
- Maintain awareness of global regulatory rules (ICH GCP, GVP, CTR).
- Provide mentorship to technical associates for ICSR management activities.
Qualifications & Skills
The ideal candidate should have:
- Strong knowledge of Good Pharmacovigilance Practice (GVP), Good Clinical Practice (GCP), and Clinical Trial Regulations (CTR).
- Experience in ICSR processing, safety databases (Argus preferred), and case coding conventions.
- In-depth understanding of medical and drug terminology.
- Proven expertise in time management, prioritization, and vendor oversight.
- Excellent communication and stakeholder management skills.
Why Join GSK?
At GSK, you’ll be part of a purpose-driven organization uniting science, technology, and talent to fight disease together. Benefits include:
- Exposure to global pharmacovigilance operations.
- Opportunities for career growth and professional development.
- A supportive work culture focused on innovation and patient safety.
Application Process
