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Safety Quality Pharmacist – France
Il y a 4 mois
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 Excelyates 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 Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.
What we offer:
Working in the pharmacovigilance department of a major pharmaceutical company, you will be responsible for:
Standard procedures
– Participate in drafting standard procedures for the Global Safety perimeter,
– Validate local SOPs relating to the organization of the PV system for marketed products.
Quality controls
– Contribute to the management of deviations/CAPAs relating to Global Safety processes and identified in particular during quality controls, external/internal audits and inspections.
PSMF
– Participate in updating the PSMF Europe and finalize the document according to the proposed schedule,
Audits – Inspections
– Participate in the preparation and follow-up of internal/external audits and inspections of the pharmacovigilance system by health authorities.
Training
– Contribute to the appropriate training of Global Safety staff.
Periodic reviews
– Organize and prepare quarterly performance reviews of the PV Global Safety quality system with EEA-QPPV, and ensure follow-up.
