Responsible Pharmacist – Quality Assurance, Regulatory & QPPV (South Africa)

About the role

BeOne is seeking a senior Responsible Pharmacist to lead quality assurance, regulatory affairs and pharmacovigilance activities in South Africa. The role will shape the company’s presence in haematology and oncology, ensuring compliance with local legislation while delivering value to patients and stakeholders.

Key responsibilities

• Develop and execute regulatory filing strategies, manage submissions, approvals and licence maintenance.
• Act as the Local Qualified Person for Pharmacovigilance (QPPV), overseeing case reporting, literature surveillance and local PV system implementation.
• Ensure GMP/GDP compliance, manage the local quality management system, support product launches and post‑marketing activities.
• Handle deviations, recalls, batch release, documentation approval and product traceability.
• Maintain communication with health authorities and internal global teams.

Required profile

• Bachelor of Pharmacy degree and registration with the South African Pharmacy Council.
• Minimum eight years of experience in regulatory affairs and quality assurance.
• Proven ability to work 24‑hour on‑call for pharmacovigilance reporting.
• Strong knowledge of SAHPRA regulations and international regulatory standards.

Required skills

• Electronic quality systems
• Regulatory dossier preparation and lifecycle management
• Pharmacovigilance case reporting and safety communication
• GMP/GDP compliance
• Quality management system administration