Roles & Responsibilities
• Lead safety case processing and support global safety evaluation activities
• Monitor compliance with PVASC requirements for GSK and third parties including HSI reconciliation
• Perform quality checks of adverse event reports in global safety databases and escalate issues
• Maintain pharmacovigilance databases, EDMS, PVASC platforms, and shared systems
• Collect, analyze, and document safety data from local operating companies
• Generate standard safety listings and manage document archiving processes
• Support regulatory inspections and internal audits under senior guidance
• Contribute to SOPs, guidance documents, and process improvement initiatives
• Collaborate with internal and external stakeholders with minimal supervision
Qualification
• Bachelor’s degree in life sciences, pharmacy, medicine, nursing, or related health science
Experience
• 5–9 years of pharmacovigilance or drug safety experience including ICSR processing
Skills
• Strong knowledge of pharmacovigilance regulations, GVP, and clinical safety documentation
• Experience with safety databases and electronic case processing systems
• Good understanding of medical terminology and MedDRA coding
• Proficiency in MS Word, Excel, PowerPoint, SharePoint, and PowerBI
• Strong organizational, analytical, and stakeholder management skills
About the Company
GlaxoSmithKline (GSK) is a global biopharmaceutical company committed to uniting science, technology, and talent to get ahead of disease together. GSK focuses on vaccines and specialty medicines to positively impact billions of patients worldwide while fostering a culture driven by integrity, innovation, and patient safety.
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