QPPV At Hi Pharm
2 to 5 years
1 open position
About the JobTraining for the field force.
Activate the Pharmacovigilance system in our company and updates it.
Prepares and updates of Pharmacovigilance system Master File of our company (PSMF).
Prepare and update the summary of Pharmacovigilance System Master File.
Save, handling, analyze and reports the individual case safety reports (ICSRs) for the Egyptian Pharmacovigilance center in the Ministry of Health (M.O.H).
Prepare the Periodic Benefit Risk Evaluation Report of our molecules (PBRER).
Preparation of the Risk Management Plan (RMP) for our molecules upon request or for registration of new drugs or for reregistration of drugs.
Communication with the M.O.H
Set the PV SOPs (standard operating procedures) which determine the duties, responsibilities and the exact procedures, and develop them according the new findings.
QPPV is in contact with PV inspections
Revise Pamphlets, Boxes, Stickers before Printing.
Support the registration SOPs
Job RequirementsPharmacist or Physician.
At least 2 years relevant experience within the medical affairs discipline.