Job Description Summary
About this role:
Job Description
Location: New Cairo, Egypt
Working model: Hybrid
Relocation Support: Novartis is unable to offer relocation support: please only apply if this location is accessible to you.
Key Responsibilities:
• Lead country patient safety strategy, ensuring compliance with local regulations and Novartis global pharmacovigilance standards.
• Serve as the primary pharmacovigilance contact for health authorities, ensuring timely, accurate, and transparent safety communications.
• Provide senior leadership and direction to the country patient safety team, fostering engagement, accountability, and capability growth.
• Ensure effective oversight of local pharmacovigilance systems, including case processing, reporting quality, and regulatory timelines.
• Drive continuous improvement of local patient safety processes, procedures, and training programs.
• Oversee implementation and monitoring of local risk management plans and pharmacovigilance commitments.
• Lead responses to safety‑related health authority requests in close collaboration with Regulatory Affairs and global stakeholders.
• Manage readiness for pharmacovigilance audits and inspections, ensuring timely corrective and preventive actions.
• Monitor performance of pharmacovigilance vendors and partners, ensuring contractual and regulatory compliance.
• Proactively assess regulatory changes and emerging safety issues, translating them into effective local actions.
Essential Requirements:
• Bachelor’s degree in Health Sciences (minimum), with a professional qualification as a Medical Doctor or Pharmacist.
• Minimum of eight years of pharmacovigilance experience in the pharmaceutical industry, including at least two to three years within a large pharmaceutical organisation.
• Strong knowledge of local and international pharmacovigilance regulations and reporting obligations.
• Demonstrated leadership experience with the ability to coach, motivate, and guide teams through change.
• Proven experience acting as a senior pharmacovigilance contact with health authorities.
• Solid understanding of pharmacovigilance quality management systems, case management, and compliance oversight.
• Strong strategic thinking with the ability to manage complex priorities and make sound, risk‑based decisions.
• Excellent communication skills in written and spoken English; good working knowledge of the local language is required.
Desirable Skills:
• Proven experience leading teams through transformation initiatives and delivering large, strategically significant projects.
• Formal project management experience is considered an advantage.
Novartis is a proud member of the ILO Global Business and Disability Network and the Valuable 500, reinforcing our commitment to inclusion and accessibility in the workplace. In Egypt and globally, we collaborate with international partners such as Disability: IN, Purple Space, and the Business Disability Forum to identify and advance best‑practice solutions that enable people with disabilities to participate as equal and valued members of our organization.
Skills Desired
Clinical Trials, Databasing, Employee Training, Management Reporting, Pharmacovigilance, Safety Science, Team Management, Waterfall Model