Pharmacovigilance & Regulatory Affairs Officer

About the role

The Pharmacovigilance & Regulatory Affairs Officer ensures that the company’s products comply with UAE pharmacovigilance and regulatory requirements, supporting patient safety and product quality throughout the product life‑cycle.

Key responsibilities

• Obtain and maintain the Pharmacovigilance licence from Emirates Drug Establishment and act as the local PV focal point.
• Collect, assess, process and report adverse events to regulators and principal companies within mandated timelines.
• Prepare, review and update PV SOPs, conduct safety literature screening and provide regulatory intelligence.
• Deliver PV training, maintain training records and promote a proactive safety culture.
• Prepare for and support audits, inspections and CAPA management, ensuring documentation is inspection‑ready.
• Manage regulatory submissions, renewals, variations and post‑approval changes with Dubai Municipality and Emirates Drug Establishment.
• Review product labels, leaflets, dossiers and promotional materials for compliance and safety alignment.
• Provide periodic PV and regulatory compliance updates to management and maintain structured communication with stakeholders.

Required profile

• Bachelor’s degree in Pharmacy, Life Sciences or related discipline.
• 4‑7 years of progressive experience in Pharmacovigilance and Regulatory Affairs within the UAE healthcare sector.
• Hands‑on experience coordinating with Emirates Drug Establishment and Dubai Municipality.
• Proven experience with Safety Data Exchange Agreements (SDEAs) and audit/inspection support.

Required skills

• Strong knowledge of UAE pharmacovigilance regulations and adverse event reporting.
• Experience with regulatory submission processes, dossier management and post‑approval changes.
• Familiarity with CAPA methodology, audit readiness and compliance risk assessment.
• Proficiency in Microsoft Office, documentation control and structured tracking tools.