Director, PV Operations – ICSR Management

Job description

Nombre del sítio: Home Worker - GBR, Belgium-Wavre, Bengaluru Luxor North Tower, Poznan Business Garden Pastelowa, Warsaw
Fecha de publicación: Feb 26 2024

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

Como empresa impulsada por nuestros valores de enfoque al paciente, transparencia, respeto e integridad, sabemos que la inclusión y la diversidad son esenciales para que podamos tener éxito. Queremos que todos nuestros colegas prosperen en GSK, brindando sus experiencias únicas, asegurándonos de que se sientan bien y que sigan creciendo en sus carreras.  Como candidato para un papel, queremos que usted se sienta de la misma manera.

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