Job Purpose
• Provides cross enterprise technical support within PV Excellence (PVE) and the business, as required.
• Supports Global Process Owners (GPOs), Safety Process Leads (SPLs) and the business, by undertaking identified operational tasks.
• Assist GPOs/SPLs to provide strategic oversight for enterprise PV processes. • Assist GPOs/SPLs to deliver creative, productive, holistic, end-to-end safety processes that are compliant with global PV regulations and reflect enterprise business needs.
• Provide operational, technical and maintenance support of appropriate PVE Workstreams
Key Responsibilities
• Undertake Template Manager Role to support PV documentation in Veeva Vault (Regulatory and Clinical)
• Support interaction between PVE and 3rd Party Vendor Activities for Aggregate Report management
• Provide support for metric collection, compilation and reporting
• Provide support for Management Monitoring
• Support access management (Submission Portal, Aggregate Report shared drive, Group Management
• Portal, Citrix Management)
• Manage and daily triage of group mailboxes • Contribute to process improvement
• Undertake role of Subject Matter Expert, when required
• Business owner of document management systems
• Review content on PVE owned webpages and ensure materials are up to date and fully operational
• Support Signal detection, including CVW and review of EMA publications for signal related data
• Support Surveillance activities
• Support RMP and Targeted Safety Study (TSS)/Post Approval Safety Study (PASS) activities including RMP coordination.
• Support eTMF
• Support Medical Devices
• Support Case Awareness Tool/Autosteers profile/TOI/MedDRA/TFQs
• Provide oversight of local Reference Safety Information updates and address queries
• Support for Development Core Safety Information management
• Support Safety Communications process
• Provide support for training, inspections, and audits Expected competencies for this role:
• Excellent organisational skil
📌 Global Safety Apprenticeship Bengaluru (India)
🏢 GSK
📍 India