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Safety Specialist
Il y a 2 mois
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.
Key ResponsibilitiesAs a Safety Specialist - Pharmacovigilance Coordinator, you will be involved in many aspects of pharmacovigilance coordination and execution at the affiliate level. You will provide back-up support to the AHoPS as required.
Key Activities:- Patient Centricity: 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.
- 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.
We are looking for a candidate with:
- Pharmacist background.
- 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.
