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Senior QPPV Specialist

Delta Pharma Egypt
Heliopolis, Cairo
Posted 4 years ago
31Applicants for1 open position
  • 28Viewed
  • 2In Consideration
  • 26Not Selected
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Job Details

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Job Description

  • Establishing, maintaining and managing Pharo Pharma Pharmacovigilance (PV) system.
  • Has access to the pharmacovigilance system master file (PSMF) and he has the authority to ensure and verify that all the contained information is an accurate and up-to-date reflection of our PV system.
  • Preparation, revision and responsible for submission of All Pharmacovigilance documents (PBRER, RMP, ACO, DHPC) to the Egyptian Pharmaceutical Vigilance Center (EPVC) within the specified time frames.
  • Is involved in the revision and sign-off of protocols of post-authorization safety studies (PASS) conducted in Egypt or pursuant to a risk management plan agreed in Egypt (when requested by EPVC);
  • Committed to EPVC meetings and in responding to all EPVC's requests including provision of correcting or completing information.
  • Deliver trainings and mentoring Pharmacovigilance staff.
  • Deliver trainings to customer facing non-PV staff on the perfect way to collect Case Safety reports and report them to PV team within the specified timeframe.

Job Requirements

  • Graduated from faculty of Pharmacy.
  • 5-7 years of Pharmacovigilance experience.
  • Finished all related PV training courses.
  • Very good command of English Language.
  • Very good Computer skills (Microsoft office and internet searching).
  • Communication and presentation skills.
  • Leadership skills.
  • Stick to tight deadlines and work under pressure.

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