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Product Safety Specialist II

Product Safety Specialist II

ID 
2017-1367
Job Location 
US-NC-Chapel Hill
Type 
Regular Full-Time

More information about this job

Overview

We are currently seeking a Product Safety Specialist II who will function as an integral part of the product safety team and will oversee the day-to-day activities for their assigned projects.

Responsibilities

  • Prepares safety related documents for assigned projects including safety management plans and site training materials
  • Collaborates with the internal project team and the sponsor to determine the scope and specifics of safety data collection, processing, and reporting for assigned projects
  • Responsible for collecting, monitoring, and processing safety reports
  • Coordinates and performs adverse event data entry, narrative writing, coding/coding review, case quality control review, follow-up, tracking of reports, and regulatory reporting activities
  • Performs intial assessment of all safety reports for potential expedited reporting to the FDA or other applicable health authorities
  • Responsible for performing reconciliation between the clinical and safety database
  • Processes safety cases in compliance with SOPs, Safety Management Plans, and applicable regulations
  • Facilitates communication between project team members and site staff
  • Works on multiple projects in compliance with mandatory timelines

 

Qualifications

  • Bachelor's degree in a scientific or health related field (e.g. RN, Medical Terminology, Pharm.D)
  • Two to five (2-5) years of product safety/pharmacovigilance experience (clinical trials experience preferred)
  • Experience utilizing a product safety database (experience using Argus a plus)
  • Proficiency in MS Office Suite and strong computer skills

 

 

EOE. Veterans/Disabled