Director, PV Operations – ICSR Management

Job title:

Director, PV Operations – ICSR Management

Company

GlaxoSmithKline

Job description

Director, PV Operations – ICSR Management

Job Purpose

The key purpose of this role is to support Pharmacovigilance Operations “PV Ops”– ICSR Management in the following activities:

ICSR Management

• Argus Configuration for new Programs/Studies
• ICSR processing
• Case Processing Coding Conventions
• Local Operating Companies (LOC) Interactions
• Functional Vendor Oversight:

• New Market Authorisation
• Withdrawal of Market
• Authorisation
• Clinical Trial/Program Interactions for:

• Study/Program Set up
• Study/ Program Maintenance
• Study/ Program Close out
• Argus Configuration for Submissions to destinations including:

• Regulatory Authorities
• Partners
• Clinical Research Organisations (CROs)
• Local Operating Companies (LOCs)
• Clinical Operations/CROs

This role is responsible for the above elements in alignment with GSK standards and regulatory timelines whilst driving the implementation of robust processes for successful PV operations activities, including vendor oversight.

Key Responsibilities:

• 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 the ICSR Management team to achieve the objectives of the group. ICSR Management team 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/HSI 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 LOCs.
• 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.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• BS/BA in a scientific or medically related field (e. g. Nurse or pharmacist) and experience in the pharmaceutical industry in clinical development, pharmocovigilance and information management, Equivalent work experience considered.
• Extensive clinical safety or related experience. Significant history of management experience.
• Experience in and in depth knowledge of GCP and GVP, CTR, CTD, 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.
• Demonstrated experience effectively working with outsourced providers.
• Project management experience.
• Experience in mapping processes and authoring written standards.
• Knowledge and experience with pharmacovigilance systems.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• High level of clinical understanding
• Excellent oral and written communication skills
• Proven ability to negotiate and influence stakeholders at upper management level.
• 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 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.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on or 0808 234 4391.

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Expected salary

Location

United Kingdom

Job date

Thu, 29 Feb 2024 06:16:41 GMT

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