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Pharmacovigilance (PV) Specialist / Drug Safety Case Processing Specialist/Clinical Trial Consultant

SSI PeopleUnited States🇺🇸United States

Why this role stands out

This hybrid role offers a fantastic opportunity to deepen your expertise in pharmacovigilance and contribute to global drug safety, with excellent potential for professional development within a reputable company. If you have a strong background in ICSR processing and a passion for ensuring regulatory compliance, you'll thrive in this dynamic environment. Apply today to advance your career in this rewarding field!

Quick overview

SeniorityMid Senior
Work modeHybrid
LocationUnited States
PharmacovigilanceTriage

Job description

Job Description:
Responsible for processing and quality checking (QC) of clinical trial and post-marketing Individual Case Safety Reports (ICSRs). Key responsibilities include case intake, triage, data entry, MedDRA coding, narrative writing, follow-up queries, case reconciliation, and ensuring timely regulatory reporting in compliance with global pharmacovigilance regulations.

Required Skills:

  • Bachelor’s degree in Science or a healthcare-related field.

  • 4+ years of experience in Pharmacovigilance.

  • Hands-on experience with ICSR processing and QC.

  • Experience with Argus, ArisG, or Veeva Safety databases.

  • Knowledge of MedDRA coding and FDA, ICH, and EU pharmacovigilance regulations.

  • Strong communication, analytical, and documentation skills.

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