Pharmacovigilance Officer

Job Description

Duties & Responsibilities:

• 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 Pharmacy with Excellent/V. Good grade is the must.

Experience & Qualifications

• 0-2 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