Pharmacovigilance & Regulatory Affairs Officer

Pharmacovigilance & Regulatory Affairs Officer

At New Country Healthcare (NCH), our journey started with a powerful vision of fostering a healthier community, guided by the vision of our Chairman, Dr Ghazi Al Koudsi. Over the last 32 years, NCH has become the leading healthcare distributor in the UAE, offering over 1500 top‑quality products from more than 50 international brands.

NCH is a people‑centric culture that thrives on collaboration, continuous growth, and innovation. We prioritize learning and development through seminars and training programs, and we maintain a supportive environment that encourages teamwork and a commitment to community health.

The Pharmacovigilance & Regulatory Affairs Officer ensures that all products meet UAE regulatory and pharmacovigilance requirements, supporting patient safety, product quality, and compliance throughout the product life cycle.

• Pharmacovigilance Governance & Licensing
  • Obtain and maintain the Pharmacovigilance licence from Emirates Drug Establishment, acting as the local PV focal point for assigned principal companies.
  • Implement and maintain PV processes and controls in line with UAE requirements and Safety Data Exchange Agreements (SDEAs).
  • Serve as the primary contact for PV coordination with regulators, principals, and internal stakeholders.
• Adverse Event Management & Safety Reporting
  • Collect, assess, process, and document adverse event reports.
  • Ensure accurate and timely safety reporting to Emirates Drug Establishment and principal companies.
  • Maintain robust PV tracking logs, case files, and data quality checks.
• SOPs, Safety Documentation & Regulatory Intelligence
  • Prepare, review, and update PV SOPs, templates, and working instructions.
  • Conduct product safety reviews and literature screening for emerging risks.
  • Monitor UAE regulatory communications and translate changes into internal guidance.
• Training, Awareness & Internal Compliance
  • Deliver PV training for employees and stakeholders.
  • Maintain training plans and attendance records.
  • Promote a proactive safety culture across teams.
• Audits, Inspections & CAPA Management
  • Prepare for PV audits and regulatory inspections.
  • Coordinate audit responses, CAPA drafting, implementation, and follow‑up.
  • Escalate compliance gaps with corrective actions.
• Regulatory Affairs Submissions & Lifecycle Management
  • Manage regulatory submissions, renewals, variations, and post‑approval changes.
  • Coordinate regional regulatory activities with partners and principals.
  • Maintain submission trackers and ensure regulatory commitments.
  • Review registration dossiers, product labels, and leaflets for compliance.
  • Ensure safety updates reflected in product information.
  • Flag inconsistencies and coordinate corrective actions.
• Quality, Batch Release, Medical Information & Promotional Review Support
  • Coordinate with Quality and Supply Chain teams for quality processes and investigations.
  • Support medical information responses with accurate safety data.
  • Review promotional materials for regulatory compliance and safety alignment.
• Reporting, Stakeholder Management & Governance
  • Prepare periodic PV and regulatory compliance updates for management.
  • Maintain structured communication with principal companies and internal teams.

• 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.
• Hands‑on experience coordinating with Emirates Drug Establishment and Dubai Municipality.
• 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.

• Strong knowledge of UAE pharmacovigilance regulations and adverse event reporting practices.
• Competence in PV case intake, triage, documentation, follow‑up, and quality checks.
• Solid understanding of UAE regulatory submission processes and product lifecycle activities.
• Ability to review and quality check product information including labels and…