Premier Research Hiring Safety Submission Specialist – Remote

Premier Research Hiring Safety Submission Specialist – Remote

18 February, 2022

About the job

Description

Position at Premier Research

Role Responsibilities

  • Collaborates with the Sponsor and internal project team on setting up the safety reporting for the clinical trial
  • Prepares and or reviews the Safety Reporting section of the Safety Management Plan
  • Reviews, supports and maintains the safety regulatory intelligence for assigned countries or studies within the safety reporting platform.
  • Applies safety reporting regulatory intelligence to all safety reporting activities
  • Submits safety reports to regulatory authorities and ethics committees via registered portals or local regulatory systems eg. Eudravigilance/FAERs etc.
  • Maintains tracking of safety submissions either using a manual tracker or a safety document distribution platform
  • Supports the preparation of expedited and periodic safety report submission status updates and KPIs, as required, for Sponsor/Customer
  • Employees may be regionally based, if there is a local requirement and in this capacity will act as a local SME and will review the safety intelligence for their region
  • Files documents according to project specific requirements (electronically or in hard copy as applicable). 
  • Forwards completed safety submission documents to clients and other relevant parties
  • Supports in the preparation of data for internal project review meetings and participates as required
  • Participates in audits and inspections as required/appropriate
  • Ensures all relevant documents are submitted to the Trial Master File (TMF) as per client/Premier SOPs for clinical trials and the appropriate system for post-marketing programs
  • Maintains a detailed understanding and stringent compliance with Standard Operating Procedures (SOPs), Working Guidance documents, global drug/biologic/device regulations, GCP/GVP guidance.

Requirements

  • Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
  • 3-5 years of experience in Pharmacovigilance Case Processing related activities
  • Working experience in Clinical Trial PV Submissions for all regions
  • Working experience in registering for submission accounts in different countries, competing submissions manually or through any System
  • Detailed knowledge and training of Eudravigilance
  • Safety Database systems and knowledge of medical terminology required
  • Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Clinical Safety and Pharmacovigilance
  • Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), (or other management/shared content/workspace) and internet.
  • Ability to work independently and in a team environment
  • Good communication and interpersonal skills, both written and spoken
  • Good organizational skills with proven ability to prioritize and work on multiple tasks and projects
  • Detail oriented with a high degree of accuracy and ability to meet deadlines

How to Apply

Apply through below link

https://www.linkedin.com/jobs/view/2920932191/?refId=KrUSdPqdKpPJ%2FkDU5ZANeQ%3D%3D&trackingId=KrUSdPqdKpPJ%2FkDU5ZANeQ%3D%3D&midToken=AQHmsj73qo3RDQ&midSig=1nbin8EIXzoa81&trk=eml-email_jobs_viewed_job_reminder_01-similar_jobs-55-similar%7Ejob%7Etitle%7Emercado&trkEmail=eml-email_jobs_viewed_job_reminder_01-similar_jobs-55-similar%7Ejob%7Etitle%7Emercado-null-fkrvld%7Ekzrglbvu%7Ej8-null-jobs%7Eview

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