Specialist, Drug Safety

Job Description

Ready to make a meaningful impact on patient safety across the Middle East Join our team as a PV (Pharmacovigilance) Specialist and play a key role in pharmacovigilance operations regulatory compliance and safeguarding patient well-being across multiple markets.

Key Responsibilities:

• Manage pharmacovigilance intake activities including reconciliation and follow-up of safety reports.
• Prepare and submit Individual Case Safety Reports (ICSRs) and aggregate safety reports in compliance with local regulations.
• Support pharmacovigilance audits inspections and inspection readiness activities.
• Deliver local PV training and promote compliance with pharmacovigilance requirements.
• Escalate safety issues appropriately and maintain accurate PV documentation and archiving.
• Act with a high degree of independence while ensuring adherence to company and regulatory standards.
• Serve as Deputy QPPV for Egypt and provide backup support for PV Responsible Persons in Libya Sudan and Yemen when required.
• Contribute to additional PV projects and continuous improvement initiatives under managerial oversight.

Qualifications & Experience:

• Pharmacy or Medical degree.
• Fluency in English and proficiency in Arabic (written and spoken).
• Minimum 1 year of Pharmacovigilance experience within a multinational company.
• Strong knowledge of Egypt Good Pharmacovigilance Practice (GVP) guidelines.
• Previous pharmacovigilance experience in other Middle Eastern countries is a plus.

Required Skills:

Preferred Skills:

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