You will be taken to GSK GCC Bangalore’s own careers page to apply. Job ID Job Code: J001986.
Job description
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 and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Inclusion at GSK: As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.
Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.
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Required skills
aggregate report management, risk assessment, process improvement, problem solving, data integrity, data-driven decision making, risk awareness, risk assessments, regulatory compliance, influencing without authority, incident investigations, gxp regulations, digital fluency, lean management, case awareness tool, medical devices, training delivery, audit support, regulatory affairs, clinical development, performance metrics analysis, surveillance activities, reference safety information management, safety communications, subject matter expertise, teamwork
