PV & Regulatory Affairs Specialist — UAE

New Country Healthcare; Dubai; On-site; AED 180,000 - 290,000; Full time

Job summary

New Country Healthcare is hiring a Pharmacovigilance & Regulatory Affairs Officer to drive UAE PV and regulatory compliance across the product life cycle. You will coordinate safety reporting, submissions, and governance with Emirates Drug Establishment and Dubai Municipality, acting as the local PV focal point.

You will manage PV processes, SOPs, training, audits, CAPA, and regulatory intelligence, ensuring inspection readiness and timely actions across internal teams and principals.

Qualifications

• Bachelor’s degree in Pharmacy, Life Sciences, or a related discipline.
• 4 to 7 years of progressive experience across Pharmacovigilance and Regulatory Affairs within the UAE healthcare sector.
• Demonstrated hands-on experience coordinating with Emirates Drug Establishment and Dubai Municipality on submissions, follow-ups, and compliance requirements.
• Proven exposure to Safety Data Exchange Agreements (SDEAs), principal company coordination, and safety reporting timelines.
• Experience supporting audits, inspections, and CAPA management in a regulated environment.

Responsibilities

• Obtain and maintain the Pharmacovigilance licence from Emirates Drug Establishment, acting as the local PV focal point for assigned principal companies in the UAE.
• Implement and maintain PV processes and controls in line with UAE requirements and agreed Safety Data Exchange Agreements (SDEAs).
• Serve as the primary point of contact for PV coordination with regulators, principals, and internal stakeholders, ensuring clear documentation of roles and timelines.
• Collect, assess, process, and document adverse event reports received from patients, healthcare professionals, and pharmacies.
• Ensure accurate and timely safety reporting to Emirates Drug Establishment and principal companies within mandated timelines and SDEA conditions.
• Maintain robust PV tracking logs, case files, and data quality checks to ensure completeness, traceability, and inspection readiness.
• Prepare, review, and update PV SOPs, templates, and working instructions to reflect regulatory updates and operational improvements.
• Conduct product safety reviews and literature screening to identify emerging risks, elevate potential safety signals, and support benefit-risk assessment.
• Monitor relevant UAE regulatory communications and translate changes into internal guidance, training, or procedural updates.
• Deliver PV training for employees and relevant stakeholders to ensure consistent identification and reporting of safety information.
• Maintain training plans, attendance records, and effectiveness checks to demonstrate compliance during audits and inspections.
• Promote a proactive safety culture by reinforcing reporting discipline and practical compliance behaviours across teams.
• Prepare for PV audits and regulatory inspections by authorities and principal companies, ensuring documentation and controls are always inspection-ready.
• Coordinate audit responses, including CAPA drafting, implementation, follow-up, and effectiveness verification.
• Escalate compliance gaps and recurring issues with clear corrective actions and prevention measures.
• Manage and follow up on regulatory submissions, renewals, variations, and post-approval changes with Dubai Municipality and Emirates Drug Establishment.
• Coordinate regional regulatory activities with regional partners and principals, ensuring alignment on timelines, requirements, and documentation.
• Maintain submission trackers and ensure regulatory commitments are met to protect product availability and minimise business disruption.
• Review registration dossiers, product labels, and leaflets to ensure compliance with UAE requirements and alignment with approved product information.
• Ensure safety updates are reflected in product information through structured coordination with principal companies and internal stakeholders.
• Flag inconsistencies, compliance risks, or safety-related gaps and coordinate corrective actions.
• Coordinate with Quality and Supply Chain teams to support quality processes, complaints, investigations, and documentation where PV or regulatory input is required.
• Support medical information responses by ensuring accuracy and consistency with approved product information and safety data.
• Review promotional and marketing materials for regulatory compliance and safety alignment, coordinating cross-functional review and flagging risks for correction prior to release.
• Prepare periodic PV and regulatory compliance updates for management, highlighting key risks, trends, actions, and deadlines.
• Maintain structured communication with principal companies and internal teams to ensure consistent documentation, timely decisions, and reliable follow-up.

Skills

UAE PV regulations

Adverse event reporting

Regulatory submissions

Dossier review & lifecycle

CAPA & audits

Education

Bachelor’s degree in Pharmacy or Life Sciences

4–7 years PV/Regulatory Affairs in UAE

Tools

Microsoft Office

Job description

New Country Healthcare is hiring a Pharmacovigilance & Regulatory Affairs Officer to drive UAE PV and regulatory compliance across the product life cycle. You will coordinate safety reporting, submissions, and governance with Emirates Drug Establishment and Dubai Municipality, acting as the local PV focal point.

You will manage PV processes, SOPs, training, audits, CAPA, and regulatory intelligence, ensuring inspection readiness and timely actions across internal teams and principals.