Deputy Qualified Person for Pharmacovigilance (Deputy QPPV)

About the role

Insight CRO is seeking an experienced Deputy Qualified Person for Pharmacovigilance (Deputy QPPV) to support its growing pharmacovigilance portfolio across the Middle East, Africa and Europe. The role will work closely with the QPPV to ensure the safety of pharmaceutical products and compliance with local and international regulations.

Key responsibilities

• Assist the QPPV in maintaining an effective Pharmacovigilance System Master File (PSMF) and related documentation.
• Act as Deputy QPPV when delegated, ensuring continuity of oversight.
• Ensure compliance with Egyptian GVP guidelines, EDA requirements and other applicable international standards.
• Prepare and maintain Risk Management Plans, aggregate safety reports and other PV documentation.
• Review Individual Case Safety Reports (ICSRs) and guarantee timely regulatory reporting.
• Support internal audits, inspections, CAPA implementation and quality improvement initiatives.
• Deliver pharmacovigilance training and support continuous learning within the team.

Required profile

• Bachelor’s degree in pharmacy or medicine.
• Minimum 3 years of hands‑on pharmacovigilance experience.
• Valid pharmacovigilance training certificates.
• Strong knowledge of the Egyptian pharmacovigilance regulatory framework and international requirements.
• Excellent English communication skills and strong attention to detail.

Required skills

• Pharmacovigilance processes and regulations.
• Medical device vigilance (preferred).
• Use of safety databases and preparation of PV documentation.

What we offer

• Opportunity to work with a regional CRO serving pharmaceutical companies across multiple continents.
• Diverse exposure to local and international PV projects.
• Collaborative and professional work environment.
• Continuous learning and career development opportunities.