Pharmacovigilance Case Processing Specialist

Ft Worth, MA

Details for the position are as follows:
  • Rate: $60 an hour
  • Location: Boston, MA
  • 12 month contract to start with the possibility of extension or conversion depending on performance and business needs
Job Description:
  • Triage, Intake, case entry and QC of ICSRs originating from Biogen sponsored studies or other assigned cases
  • Includes narrative writing, MedDRA coding, drafting of follow-up queries and event notifications to internal stakeholders
  • Perform retrospective quality checks on processed cases
  • Independently manage assigned cases, accounting for weekends and holidays, to deliver cases to internal stakeholders on time and ensure case completion allowing for on-time regulatory reporting
  • Review and resolution of reconciliation issues between the clinical and safety databases per in collaboration with Data Management
  • Provide investigation details into late regulatory reporting of CT cases
Required Skills:
  • Bachelor’s degree in science or healthcare related field
  • 4+ years experience in pharmacovigilance
  • Experience with ICSRs case processing required



 

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