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Pharmacovigilance Officer - 6 October Plant

Hikma Pharmaceuticals
6th of October, Giza
Posted 3 years ago
440Applicants for1 open position
  • 82Viewed
  • 39In Consideration
  • 0Not Selected
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Job Details

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Job Description

  • Contribute to the update of the national pharmacovigilance sub system file (PSSF)
  • Receive, follow up, and report Egypt adverse events (AEs) from spontaneous reports and Hikma-sponsored clinical studies
  • Communicate and perform reconciliation with relevant personnel, affiliates, partners and service providers
  • Perform literature searching in Egypt
  • Monitor Egypt PV regulatory requirements
  • Respond to requests from Egypt regulatory authorities
  • Prepare Egypt PV aggregate reports (periodic safety update reports (PSURs), addendum to clinical overviews (ACOs))
  • Prepare risk management plans (RMPs) and contribute to the implementation of risk minimization measures (RMMs) in Egypt
  • Contribute to preparation/review safety data exchange agreements (SDEAs) with Egypt partners and distributors
  • Participate in preparation/review of Egypt PV standard operating procedures (SOPs)
  • Conduct PV training for Egypt personnel
  • Maintain the list of Egypt products up-to-date on the Global Product Portfolio.

Job Requirements

  • Education: BSc. of Science - Pharmacy with Excellent/V. Good grade is the must.
  • Experience: 1-5 years of experience in the same position.
  • Skilled team player with interpersonal skills and a tracking record of successfully working
  • Excellent written and verbal communication skills/ analytical and organizational skills

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