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Drug Safety Professional

1 tydzień temu

Warszawa, Mazovia, Polska Theramex Germany GmbH Pełny etat
Responsibilities

The ideal candidate will be responsible for:

  • PV Compliance Monitoring: Monitor PV compliance indicators for the Theramex Global PV team.
  • Vendor Compliance: Ensure third-party vendors comply with PV requirements.
  • Audit Planning and Execution: Plan and execute PV inspections/audits of external bodies, such as Health Authorities and partner companies globally.
  • CAPA Management: Implement and track CAPA plans for audits/inspections of Theramex.
  • Reporting and Communication: Communicate audit/inspections findings with the relevant QPPV for the territories impacted.
  • eQMS System Administration: Manage the Theramex eQMS system for compliance-related activities.
  • Case Processing and Review: Process cases, including data entry, review, and assessment of AE/SAE reports.
  • AE/SAE Reconciliation and Review: Perform AE/SAE reconciliation and review.
  • Literature Research: Conduct research on global and local literature sources.
  • EudraVigilance Submissions: Engage in EudraVigilance activities, including submitting ICSRs.
  • Signal Detection and Analysis: Participate in the signal detection process for Theramex products.
  • Process Development and Enhancement: Contribute to the development and enhancement of Theramex PV processes.