Full Time
International New -
Egypt , Cairo
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International New
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Job Details

Experience 2 to 5 years
Salary Confidential
Employment Full Time
Education Bachelor's Degree","translations":{"name":{"ar":"درجة البكالوريوس","en":"Bachelor's Degree
Industry Pharmaceuticals
  • Serve as the Qualified Person for Pharmacovigilance (QPPV) and ensure compliance with all pharmacovigilance regulations and guidelines.
  • Monitor, collect, and evaluate adverse event reports from various sources, ensuring timely and accurate documentation.
  • Prepare and submit periodic safety update reports (PSURs), risk management plans (RMPs), and other regulatory documents as required.
  • Liaise with regulatory authorities and respond to safety-related queries and inspections.
  • Maintain and update the pharmacovigilance system master file (PSMF), including SOPs, trackers and KPIs and ensure its ongoing compliance.
  • Performing Literature Search on weekly basis and addressing any emerging safety issues.
  • Conduct signal detection and risk assessment activities to identify potential safety issues.
  • Develop and deliver pharmacovigilance training to internal teams and external partners as needed.
  • Collaborate with cross-functional teams including regulatory affairs, clinical development, and quality assurance.
  • Ensure timely escalation and communication of safety concerns to relevant stakeholders.
  • Stay current with changes in pharmacovigilance regulations and best practices.

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Egypt, Cairo
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