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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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