PV & Regulatory Affairs Officer

About the role

New Country Healthcare is looking for a Pharmacovigilance & Regulatory Affairs Officer to act as the local focal point for safety reporting and regulatory compliance in the UAE. The role ensures products meet UAE regulatory and pharmacovigilance requirements across the full product life cycle, working within a matrix governance model where final ownership and approvals remain with designated functions.

Key responsibilities

• Obtain and maintain the Pharmacovigilance licence from Emirates Drug Establishment and implement PV processes in line with UAE requirements and Safety Data Exchange Agreements (SDEAs)
• Collect, assess and document adverse events and report them accurately and on time to regulators and principal companies
• Maintain PV tracking logs, case files and data quality checks
• Prepare and update PV SOPs, templates and working instructions, and conduct product safety reviews and literature screening
• Deliver PV training, maintain training records and promote a proactive safety culture
• Prepare for PV audits and inspections, coordinate CAPA drafting, implementation and follow-up, and escalate compliance gaps
• Follow up regulatory submissions, renewals, variations and post-approval changes with Dubai Municipality and Emirates Drug Establishment
• Review registration dossiers, labels and leaflets, and support quality, batch release, medical information and promotional review processes
• Report periodic PV and regulatory compliance updates to management

Required profile

• Bachelor's degree in Pharmacy, Life Sciences or a related discipline
• 4 to 7 years of progressive experience in Pharmacovigilance and Regulatory Affairs within the UAE healthcare sector
• Experience coordinating with Emirates Drug Establishment and Dubai Municipality, and with principal companies under SDEAs
• Experience supporting audits, inspections and CAPA management

Required skills

• Working knowledge of UAE pharmacovigilance regulations, adverse event reporting and regulatory submission processes
• PV case intake, triage, documentation, follow-up and quality checks
• Product information review, including labels and leaflets
• CAPA methodology, audit readiness and basic compliance risk assessment
• Strong Microsoft Office skills and use of structured trackers