Drug Safety Specialist

il y a 1 semaine


BoulogneBillancourt, Île-de-France Excelya Temps plein
About the Role

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 Responsibilities

As a Safety Specialist - Pharmacovigilance Coordinator, you will be involved in many aspects of pharmacovigilance coordination and execution at the affiliate level. Your primary responsibilities will include:

  • Pharmacovigilance Project Coordination: 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, and perform system admin review and cleanup of former and active PV Transfer Projects in the Smartsheet application.
  • Patient Centricity and Alliance Management: 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, and assist with Safety Data Exchange Agreement (SDEA) data collection during Due Diligence for Outbound PV Transfer Projects.
  • Passive Safety Surveillance (PASS): Manage, track and reminders to Epidemiologist to update PASS tracker, manage updates to PASS pgMO Sharepoint Site, create study-level documents and resources from templates, and assist with standardized communications and follow-up.
  • Transfer of Medical Files (TMF): Support transfers of TMF for coordination with IN Hub Resource for Sequoia (Veeva Vault CMS) migration and Quality Control.
Requirements

To be successful in this role, you will need to possess the following skills and qualifications:

  • Pharmacist degree
  • 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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