WHO WE ARE

Will be a major player in the healthcare sector, committed to manufacturing and distributing high quality pharmaceutical products, to improve human health and well-being.
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CONTACT INFO
  • Address: Zone 5A Industrial Area,No. 64,
    10th of Ramadan, Egypt
  • Phone: (20554) 410 901/902/903/904/905
  • Email: info@wnb-eg.com
1 available

01.QPPV - Qualified Person for Pharmacovigilance - [Ref: RA-01]

REQUIREMENTS
  • Bachelor degree of pharmaceutical sciences.
  • 2-4 Years’ Experience in well-established Pharmaceutical company.
  • Good communication and presentation skills.
  • Well performing in Team work and under stress.
  • Good command of Microsoft application (Excel, Power point, word) .
Must have the Training courses for the Pharmacovigilance with Certificates for attending the following courses
  • Training on the common Arab Guidelines in Pharmacovigilance (Risk Management Systems & Risk Minimization Measures).
  • Training on the common Arab Guidelines in Pharmacovigilance (ICSRs Management and Reporting) .
  • Training on the common Arab Guidelines in Pharmacovigilance (Signal Detection & Post Authorization Safety Studies PASS) .
  • Training on the common Arab Guidelines in Pharmacovigilance (Pharmaco epidemiology and Biostatics, Pharmacokinetics and Pharmacodynamics & Evidence based medicine).
  • Training on the common Arab Guidelines in Pharmacovigilance (Pharmacovigilance Master File (PSMF), Pharmacovigilance System and their quality& PV inspection and PV audit).
  • Training on the common Arab Guidelines in Pharmacovigilance (Periodic Safety Update Report (PSUR)).
  • Training on the common Arab Guidelines in Pharmacovigilance, practical hand - on training how to construct PSMF, PBRER and RMP).
  • Training on the common Arab Guidelines in Pharmacovigilance, on PV regulations in RCTs, Vaccinovigilance, biological and biosimilars medicinal products, reporting in medication errors in PV, medical aspects of ADRs, case narrative writing for ICSRs and evidence based medicine.
  • Refreshment training on the common Arab Guidelines in Pharmacovigilance (Periodic Safety Update Report (PSUR)).
JOB DESCRIPTION
  • Acts as a contact person for local regulatory authorities, healthcare professionals and consumers for drug safety and PV activities.
  • Receives, follows-up, and reports spontaneous reports of adverse events and other safety information to relevant PV staff and to local regulatory authorities as applicable.
  • Ensures the active monitoring of local pharmacovigilance regulations.
  • Responds to requests for safety information from local regulatory authorities.
  • Receives, follows-up, reports and monitors customer complaints and medical information enquiries.
  • Performs local literature searching.
  • Ensures training on pharmacovigilance for local employees.
  • Ensures the archiving of local PV documentation.
  • Reviews/Quality Check of product labelling documents against Company Core Data Sheet (CCDSs) and accepted references.
  • Reviews of Safety Data Exchange Agreements (SDEAs).
  • Prepares periodic update safety reports (PSURs)/risk management plans (RMPs).
  • Co-ordinates & ensures implementing local risk minimization measures.
  • Co- ordinate in preparing the English and Arabic leaflets concerning company products.
  • Co- ordinate in preparing the scientific files as per the non-referenced products under registration.

You are welcome to send your CV to e-mail: careers.ra@wnb-eg.com - Including with Job Ref in Subject Line