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Patient Safety & Pharmacovigilance Officer

2+ years
Not Disclosed
10 Dec. 12, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Overview:

At Excelya, we offer a personal and authentic experience within a dynamic, young health company that is on track to become the clinical research leader in Europe. With a dedicated team of 800 Excelyates, we provide a unique one-stop service model that combines full-service, functional service provider, and consulting solutions. This enables our team members to evolve through a diverse range of projects, working alongside leading experts to advance scientific, managerial, and human knowledge to improve patient journeys.

At Excelya, excelling with care means offering our employees a stimulating professional environment that encourages personal, intellectual, and operational contributions. We are committed to empowering each Excelyate to express their natural talents, develop their full potential, and invest their unique selves into our shared mission.


Position: PSPV Alliance and PASS Support Specialist
Location: [Insert Location]
Job Type: Full-time


Job Description:

As a PSPV Alliance and PASS Support Specialist at Excelya, you will support the management of safety data exchange projects and epidemiological tracking processes within our organization. This role involves coordinating various phases of PV Transfer Projects, assisting with data collection and reporting, and contributing to the efficient management of our PASS (Post-Authorisation Safety Study) activities. You will collaborate with internal teams to prepare reports, maintain project trackers, and help ensure seamless communication across workstreams.


Key Responsibilities:

PSPV Alliance Management:

  • Project Tracking: Support the management of the PV Transfer Projects data tracker using Smartsheet.
  • Project Coordination: Assist in coordinating PV Transfer Projects across the Due Diligence, Active Inbound, and Active Outbound phases.
  • System Maintenance: Perform system admin tasks, including review and cleanup of past and current PV Transfer Projects within Smartsheet.
  • Materials Preparation: Collaborate with PSPV Alliance Management Training & Orientation and Communication workstreams to prepare materials and update intranet sites.
  • Report Preparation: Prepare reports and slide decks for QPPV meetings regarding PV Transfer Projects.
  • Safety Data Exchange: Assist in Safety Data Exchange Agreement (SDEA) data collection during the Due Diligence phase for Outbound PV Transfer Projects.

PASS (Post-Authorisation Safety Study) Support:

  • PASS Tracker Management: Track and remind Epidemiologists to update the PASS tracker and assist with updates as needed. (Training to be provided)
  • SharePoint Updates: Manage and update the PASS pgMO SharePoint Site with relevant information.
  • Study-Level Documents: Create study-level documents and resources using templates in Smartsheet, Teams, and SharePoint libraries. (Training provided)
  • Standardized Communications: Assist with creating standardized communications and follow-up actions.
  • TMF Transfers: Support the transfer of TMF for coordination with the IN Hub Resource for Sequoia (Veeva Vault CMS) migration and quality control.

Qualifications:

  • Preferred Experience: Experience with Smartsheet, SharePoint, and Veeva Vault CMS is a plus.
  • Skills: Excellent communication, organizational, and project management skills.
  • Attention to Detail: Strong ability to track, organize, and report project activities accurately.
  • Collaboration: Ability to work closely with cross-functional teams and contribute to effective communication and workflow management.

What We Offer:

At Excelya, we are committed to providing our employees with a unique, enriching experience that fosters personal growth and intellectual development. Join us in making an impact on clinical research and improving the patient journey.
 

Minimum Requirements:

  • Pharmacist or Master’s Degree in a relevant field.
  • Specialized expertise at every stage of the product life cycle.
  • Strong aptitude for IT tools and technology.

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