Regulatory Affairs & Pharmacovigilance Pharmacist

About the role

The role ensures business compliance with all relevant pharmaceutical regulations, oversees the development and maintenance of SOPs, and leads regulatory affairs and pharmacovigilance activities for clients in East Africa.

Key responsibilities

• Initiate, implement, review and update SOPs and process flows to meet current regulatory requirements.
• Apply for import, export and dangerous drugs permits, and compile quarterly reports for the Pharmacy and Poisons Board.
• Maintain product registration status, support renewals, and submit change notifications for registered products.
• Act as the Qualified Person for Pharmacovigilance, manage the safety database, and report adverse events (ICSRs, PSURs) to authorities.
• Coordinate audits, CAPA actions and non‑conformance handling, and communicate regulatory updates to clients.
• Lead training and development of staff on regulatory and pharmacovigilance matters.

Required profile

• Bachelor of Pharmacy and registration with the Pharmacy and Poisons Board.
• Minimum 1 year experience as a Qualified Person for Pharmacovigilance and at least 3 years in a pharmaceutical manufacturing or distribution environment.
• Proven ability to lead a team and work under pressure.

Required skills

• Working knowledge of CAP 244 and Pharmacy and Poisons Board regulations.
• Experience with pharmacovigilance reporting (ICSRs, PSURs).
• SOP development and regulatory affairs processes.
• Use of safety databases and risk‑management plans.