Safety Specialist
il y a 4 semaines
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 900 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.
Key Activities :
This position is involved in many aspects of pharmacovigilance coordination and execution at the affiliate and will provide back-up support to the AHoPS as required. Patient Centricity:
PSPV Alliance Management:
- Support management of the PV Transfer Projects data tracker in the Smartsheet application
- Assist in the coordination of PV Transfer Projects in the Due Diligence, Active Inbound and Active Outbound phases
- Perform system admin review and cleanup of former and active PV Transfer Projects in the Smartsheet application
- Work with the PSPV Alliance Mgmt Training & Orientation and Communication workstreams to prepare materials and update intranet sites
- Prepare PV Transfer Project reports and slide decks for required QPPV meetings 6) Assist with Safety Data Exchange Agreement (SDEA) data collection during Due Diligence for Outbound PV Transfer Projects
PASS:
- Manage, track and reminders to Epidemiologist to update PASS tracker. Business Archive Coordinator (BAC) for PASS (activity to be trained)
- Manage updates to PASS pgMO Sharepoint Site
- Create study-level documents and resources from templates (e.g. in Smartsheet, Teams, Sharepoint libraries); activity to be trained
- Assist with standardized communications and follow-up
- Support transfers of TMF for coordination with IN Hub Resource for Sequoia (Veeva Vault CMS) migration and Quality Control
Profile :
• Pharmacist
• Practical experience in pharmacovigilance is beneficial
• Basic understanding of drug safety regulations and obligations is beneficial
• Teamwork and ability to propose new ideas
• Ability to maintain confidentiality (especially on patient’s records), quality and accuracy
• Good communication skills
• Good written and spoken English is essential
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