Global Safety Apprenticeship

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About the role

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 innovative, efficient, 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 skills • Demonstrates ability to work with tight deadlines under pressure, while maintaining a high level of accuracy, attention to detail and integrity • Functions as a team player • Demonstrates ability to effectively communicate (written and verbal) • Ability to effectively handle and appropriately escalate issues based on risk in a timely manner • Awareness of PV processes and global PV regulations • Preferred knowledge of process improvement techniques and ability to analyze performance metrics to drive continuous improvement • Preferred knowledge of other related disciplines e.g. clinical, regulatory affairs, clinical statistics relevant to aggregate report writing and clinical development • Demonstrates ability to be able to work independently, in a flexible manner and adjust to change. Skills Data-Driven Decision Making, Data Integrity, Digital Fluency, GxP Regulations, Incident Investigations, Influencing Without Authority, Lean Management, Problem Solving, Regulatory Compliance, Risk Assessments, Risk Awareness     Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive

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