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Case Specialist / Local Safety Officer - VAF205

Case Specialist / Local Safety Officer - VAF205

ProductLife GroupPoland
18 dni temu
Opis pracy

Group 10 Responsibilities

Case Management & Review

  • Collect and assess reports of adverse events from healthcare providers, patients, and healthcare systems.
  • Perform medical review of safety reports, analyzing patient history, dosage, and the timing of adverse events.
  • Query and conduct further assessments when necessary to clarify the nature of adverse reactions.
  • Ensure quality control (QC) for post-marketing cases.

Documentation & Compliance

  • Create and maintain detailed case reports, ensuring accurate documentation in pharmacovigilance databases (Argus, SafetyEasy).
  • Submit safety reports to regulatory agencies such as the FDA, EMA, and relevant national authorities.
  • Ensure compliance with Good Pharmacovigilance Practices (GVP) and local regulatory requirements.

    • Regulatory & Client Communication

  • Act as the Local Safety Officer (LSO) on behalf of PLG clients in Poland, including acting as the Local Pharmacovigilance Person (LPPV) nominated to the authorities.
  • Conduct local regulatory intelligence screening, tracking updates from health authorities.
  • Support and contribute to local pharmacovigilance (PV) activities performed by the Pharmacovigilance / Medical Information teams.

    • Audits & Inspections

  • Participate in audits, inspections, and contribute to action plans to maintain compliance with regulatory and company standards.

    • Group 12 Experience

  • Degree in Pharmacy or Life Sciences.
  • Minimum 3 years of experience in pharmacovigilance (PV), with a focus on post-marketing case processing and QC.
  • Proven ability to meet deadlines and work efficiently under pressure.
  • Experience in client communication related to pharmacovigilance matters.
  • Knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practices (GVP).
  • Hands-on experience with pharmacovigilance databases (e.g., Argus, SafetyEasy).
  • Strong attention to detail, organization, and reliability.
  • Knowledge of local Poland and international regulations.
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint).
  • Experience handling local case management activities (e.g., translation, data entry, QC, tracking, follow-up requests).
  • Fluency in Polish; fluency in French is nice to have.
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    Safety • Poland

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