AddressPosted Date: Mar 15 2024
Key Responsibilities
Contribute to creation or development of PV Ops processes and written standards
Collaborate with stakeholders (e.g., the Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs), and Clinical Operations/Sciences/Development) to ensure that documentation and processes are in place to achieve successful recording and reporting of safety data during the life cycle of a clinical trial and marketed product.
Work across a complex matrix environment to ensure compliance with internal standards and external regulatory requirements
Where process or training issues are identified, facilitate investigation into root cause, creation of corrective/preventative actions (CAPAs), and support with remediation of process/training needs
Review and maintain oversight of PV Operations training materials
Work with content owners and experts to prepare internal and external presentations as required
Implement changes to PV Ops training curriculums in line with current PV Ops structure and maintain oversight of PV Ops training aspects
Manage PV Ops Optimisation mailboxes for responsible workstream and respond to allocated queries in a timely manner.
Facilitate, where required to assess the impact of changes to Pharmacovigilance regulations and track implementation of changes required
Track and oversee regulatory enquiries sent to PV Ops, ensuring appropriate, thorough and timely responses
Coordinate appropriate archiving, in line with GSK Global Archiving processes, ensuring the successful retrieval of documentation and supporting inspection-readiness
Where problems or issues are identified, escalate to PV Ops Optimisation Manager / Director, as appropriate
Generate new ideas and proposals for global implementation; contribute to advancement of PV Ops methodology and optimization of processes.
Coordinate PV Ops involvement in audits and inspections
Demonstrate GSK values
Ensure appropriate prioritisation and time management, in line with business needs
Build external relationships with key stakeholders and senior leaders
Ensure relevant PV OPS Optimisation-related oversight to the (PV OPS) Directors
Resolve issues and concerns within the PV OPS Optimisation team and where resolution is not possible or there is impact across PV OPS escalate to PV OPS Optimisation Director,
Ensure PV OPS Optimisation activities are appropriately resourced and escalate any resourcing issues
Develop and identify training requirements and establish a required training plan for individuals
Provide workload forecasts to PV Ops Directors and work with Director to strategically plan, in line with business goals
Use influencing skills to drive best practice and innovation across PV Ops
Enhance matrix management across PV Ops, ensuring successful connections with PV Ops sub teams
Why Us?
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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