Pharmacovigilance QC Reviewer II

Plainsboro, NJ

Currently I have an opening for a Pharmacovigilance QC Reviewer located in Plainsboro, NJ (Hybrid Schedule). Details for the position are as follows:
Job Description:
  • In-depth pharmacovigilance case handling from case intake to submission of Individual Case Safety Reports (ICSRs)
  • Extensive quality control of ICSRs to ensure compliance to internal and external health authority regulations (21 CFR FDA PostMarketing).
  • Experience and familiarity working in safety databases (e.g., Argus)
  • Identifies nonconformance and communicates via feedback or escalation as needed
  • Education Level: Minimum bachelor’s degree, HCP degree is required e.g., pharmacist or nurse; advanced degree preferred
  • Experience Level: 3+ Years of in Pharmacovigilance Case Processing
  • Analytical thinker with proficiency working with safety databases
  • Proficiency in MS Outlook, Excel, Word,
  • Excellent written and verbal communication skills
Technical Information:
  • Pay: $29.75 hourly
  • Hybrid Schedule: Onsite 3 days, remote 2 days per week
  • 12-month contract, potential for extension

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