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QPPV Section Head

Pharaonia Pharma - Cairo, Egypt

QPPV Section Head

Pharaonia Pharma - Cairo, EgyptPosted 1 month ago
27Applicants for1 open position
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Job Details

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Job Description

  • Review of the pharmacovigilance plan implemented in the previous year.
  • Preparing the annual plan for the current year of the Pharmacovigilance Department, in accordance with the requirements of the online EURD List & Registration Department.
  • Matching the files related to pharmacovigilance that were implemented during the year "Hard & Soft" while keeping the CDs of the files submitted to the Ministry of Health.
  • Coordination with the Registration Department to review the files related to the registration/re-registration of the Products to ensure receiving the approvals of the files submitted to the Ministry of Health.
  • Reviewing and matching the paid receipts for the file delivery and attaching them to the previous year's plan.
  • Preparing the Pharmacovigilance System Master File quarterly and continuously updating it according to any new changes in the Pharmacovigilance Department / Ministry of Health requirements.
  • Prepare monthly PSUR, ACO&RMP reports and send them to the Ministry of Health.
  • Send requests to pay the file fees to the treasury manager and send those fees to the Ministry of Health.
  • Communicate with the departments of registration, marketing, research, and development to complete the preparation of pharmacovigilance files.
  • Receiving the complaints of the products received from the advertising representatives and sending them to research, development, and quality assurance departments.
  • Reviewing recent studies related to everything new and related to monitoring and evaluating the effectiveness and safety of preparations and attaching them with their file.
  • Preparing and reviewing SOPs for the Pharmacovigilance Department on an ongoing basis to follow up on the Expiration Date.
  • Attending the meetings of the Ministry of Health and the Department of Pharmacovigilance.
  • Preparing the DPHC report regarding the warning material that will be distributed to the delegates to communicate with the current doctors

Job Requirements

  • Physician /Pharmacist  ONLY
  • 3 to 5 Years of Experience.
  • Excellent Medical background.
  • Certified PV person. (full PV courses or PV Diploma)
  • English (spoken and writing skills).
  • Microsoft office skills and other computer skills and internet surfing.
  • Leadership skills
  • Planning& organizing Skills

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