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Sr. Product Safety Specialist (REMOTE)

  • Location: United States of America
  • Job Type:Contract

Posted about 1 month ago

  • Sector: Clinical
  • Contact: Laura Caswell
  • Contact Email: L.Caswell@SciProGlobal.com
  • Contact Phone: 3107734981
  • Duration: 6MTH
  • Expiry Date: 13 June 2021
  • Job Ref: 151431

Our client is currently looking for a Product Safety Specialist who will oversee the day-to-day activities include leading studies from a safely perspective, review protocols from a safety perspective.

Responsibilities:

  • Prepare safety related documents (incl. safety management plans and site training materials)

  • Collaborate with the internal project team and the sponsor to determine the scope and specifics of safety data collection, processing, and reporting

  • Collect, monitor, and process safety reports for assigned projects

  • 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

  • Perform initial assessment of all safety reports for potential expedited reporting to the FDA

  • Responsible for performing reconciliation between databases

  • Process safety cases in compliance with SOPs, Safety Management Plans, and applicable regulations

​Successful candidates will have the following:

  • BA in scientific or health related field (RN, Medical Terminology, Pharm.D)

  • 2-5yrs of product safety/pharmacovigilance experience (clinical trials experience highly preferred)

  • Systems experience - product safety database (Argus is a plus), proficiency in MS Office Suite and overall strong technical computer skills

  • Strong communication skills both verbal and written

  • Comfortable in high pressure environments with multiple projects in compliance with mandatory timelines