Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care. We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates.
Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our team to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey. For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each staff member the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.
Main responsibilities :
Deviations to Pharmacovigilance Processes:
- Audits and Inspections
- Self-Identified deviations
- CAPA Management
Quality Documents Management:
- Ensure the maintenance of PV Quality Documents System by supporting their creation and update as per quality documents life cycle management.
- Guide authors/owners as Subject Matter Expert for safety and vigilance activities and quality assurance
- Oversee PV quality document schedule including: Coordination of QDs plans, coordination of the QDs review/approval process, tracking and reporting status
- Coordinate implementation of change control process for main changes impacting the PV system from including corresponding CAPA management from review, approval, tracking, monitoring, reporting to effectiveness checks
- Support GPS/PV/Safety Functions on the review of the Global Pharmacovigilance System Master File (PSMF) and Local PSMF as applicable.
- Ensure review and timely update of the annexes/sections related to QMS including quality documents, audits findings and CAPA updates as well as audit notes
- Develop and deliver training related to PV QMS
- Ensure quality review of the yearly training program regarding Vigilance activities
- Contribute to training compliance monitoring
- Establish best practices among affiliates by supporting them with necessary guidance on PV QMS
- Provide support to PV and/or QA local functions in conduct of compliance investigations regarding activities impacting the PV System
- Monitor Local deviations to PV processes (self-identified deviations, or deviations raised via audits and inspections) for EUQPPV oversight and PSMF update
Key Performance Indicators (KPI):
- Implement and tracks Quality KPIs
- Provides quality updates for EU QPPV oversight and escalate main issues as appropriate
- Ensures KPIs for PV system are in place and are tracked by the relevant functions and that relevant issues are reported to Quality system
- Contribute to development of quality objectives related to PV QMS that are aligned with the Global Quality objectives.
- Contribute to periodic reviews of PV QMS
- Provides Advisory support for quality matters to PV staff and main interfaces
- Support transversal quality projects (e.g. Quality Alert reporting, E2E Labelling etc)
- Act as Subject Matter Expert (SME) for PV QMS topics
- Comply with applicable EHS regulations and procedures.
- Participate in the site’s EHS performance by reporting risks, malfunctions or improvements
- Participate in mandatory EHS training