PV Assistant

PrimeVigilanceRaleigh, NC

About The Position

PrimeVigilance is a global pharmacovigilance specialist that helps clients navigate complex regulations while keeping patient safety at the center of every decision. This role involves processing safety data, spotting signals early, and turning them into actionable insights. The company fosters a culture of kindness, flexibility, growth, and belonging, where colleagues support each other and good ideas are heard. This position offers a role with real purpose, global reach, and the chance to keep growing while helping to protect patients.

Requirements

  • High school or university graduate
  • Experience desirable, but not required in administrative position
  • Good communication skills
  • Experience with administrative work
  • English - advanced (spoken, written)
  • Advanced literacy (MS Office)

Responsibilities

  • Receiving and returning safety messages and acknowledging receipt, tracking and filing of Individual Case Safety Reports (ICSRs) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines.
  • Performing other miscellaneous administrative tasks, as applicable.
  • Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to): Processing Individual Case Safety Reports (ICSRs) that require simple processing (e.g. solicited cases with limited information, minimal information reports, E2B cases without narrative writing, data clean-up activities and standardised form reports) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines.
  • Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager.
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