Key Responsibilities
Core Accountabilities
Contribute to all aspects of case handling activities from case receipt to expedited reporting and collaborate with stakeholders (i.e., the Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs) and clinical operations/sciences) 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 drive high-quality delivery of case management activities that comply with internal standards and external regulatory requirements; where problems or issues are identified, facilitate investigation into root cause and create corrective/preventative actions (CAPAs)
Escalate identified problems or issues to the appropriate Management Personnel with PV Operations
Generate new ideas and proposals for global implementation; contribute to advancement of PV Operations methodology and processes.
Ensures third parties/vendors develop and implement robust processes to support quality-driven organization.
Demonstrate GSK values
Director, PV Operations – ICSR Management
Provides leadership to ICSR to achieve the objectives of the group. ICSR is responsible for the oversight of outsource partners processing approximately 300,000+ cases entered into the GSK global safety database annually. Additionally, ICSR maintains the quality management system for the global safety database and supports key internal stakeholders
Leads and drives the implementation of the PV strategy to ensure compliance with all relevant regulatory requirements, to include activities performed within GSK and by outsourcing providers; this strategy includes establishing and conducting relevant monitoring activities and ensuring business risks related to case processing activities are effectively mitigated
Accountable for oversight of expedited reporting of adverse event report to regulatory agencies and ensuring that clinical trial activities conform with ICH Good Clinical Practice requirements and GVPs
Delivers consistent, compliant, and efficient processes that are improved continuously, ensuring timely and successful remediation of process deficiencies
Ensures internal and external audit/inspection preparedness including the development of responses and implementation of corrective/preventative actions (CAPA) as a result of audit findings
Ensures robust processes that enable adverse event/HIS data is made immediately available to the SERM teams and Shared Safety Sciences for signal detection and clinical development planning
Ensures effective collaboration across all case management teams, particularly with the US and Japan LOC’s
Accountable for establishing, adjusting, and maintaining key performance indicators (KPIs) for the case management operation activities
Builds external relationships to ensure successful delivery of outsourced work
Other Job-Related Skills
Extensive clinical safety or related experienceSignificant history of management experience
Demonstrated experience effectively working with outsourced providers
High level of clinical understanding
Excellent oral and written communication skills
In depth knowledge of GCP and GVP, clinical safety documentation and reporting of adverse events from clinical trials, local regulatory requirements and pharmacovigilance methodology; general understanding of world-wide regulatory requirements for PV
Proven ability to negotiate and influence stakeholders at upper management levels
Deep knowledge of principles of data collection, analysis and retrieval and experience summarizing data
Knowledge of GSK products and awareness of business-unit specific considerations
In depth understanding of medical and drug terminology
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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