Pharmacovigilance & Regulatory Affairs Officer

About the role

The Pharmacovigilance & Regulatory Affairs Officer ensures that all company products comply with UAE pharmacovigilance and regulatory requirements, supporting patient safety and product quality throughout the product life‑cycle. Acting as the local PV focal point, the officer coordinates safety reporting, regulatory submissions and compliance activities with Emirates Drug Establishment, Dubai Municipality and internal teams.

Key responsibilities

• Obtain and maintain the Pharmacovigilance licence from Emirates Drug Establishment for assigned principal companies.
• Implement and sustain PV processes and controls in line with UAE regulations and Safety Data Exchange Agreements.
• Collect, assess, process and document adverse event reports, ensuring timely reporting to regulators and principal companies.
• Maintain PV tracking logs, case files and data quality checks to guarantee inspection readiness.
• Prepare, review and update PV SOPs, templates and work instructions as regulatory updates occur.
• Conduct product safety reviews, literature screening and signal detection to support benefit‑risk assessments.
• Deliver PV training, maintain training records and promote a proactive safety culture.
• Prepare for audits and inspections, coordinate audit responses and manage CAPA activities.

Required profile

• Ability to act as the local PV focal point and liaison with regulators, principal companies and internal stakeholders.
• Capability to obtain and maintain the required Pharmacovigilance licence.
• Experience in managing adverse event reporting and safety documentation under UAE regulations.

Required skills