• Roles and ResponsibilitiesPharmacovigilance Governance & LicensingObtain 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.
• Adverse Event Management & Safety ReportingCollect, 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.
• SOPs, Safety Documentation & Regulatory IntelligencePrepare, 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, escalate potential safety signals, and support benefit-risk assessment.
• Monitor relevant UAE regulatory communications and translate changes into internal guidance, training, or procedural updates.
• Training, Awareness & Internal ComplianceDeliver 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.
• Audits, Inspections & CAPA ManagementPrepare 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.
• Regulatory Affairs Submissions & Lifecycle ManagementManage 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.
• Label, Leaflet & Dossier ReviewReview 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.
• Quality, Batch Release, Medical Information & Promotional Review SupportCoordinate 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.
• Reporting, Stakeholder Management & GovernancePrepare 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.

• Qualifications & SkillsEducation & ExperienceBachelor’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.
• Technical & Functional SkillsStrong working knowledge of UAE pharmacovigilance regulations, adverse event reporting practices, and inspection expectations.
• Competence in PV case intake, triage, documentation, follow-up, and quality checks, with strong recordkeeping discipline.
• Solid understanding of UAE regulatory submission processes, dossier structure, product lifecycle activities, and post-approval changes.
• Ability to review and quality check product information, including labels, leaflets, and supporting registration documentation.
• Working knowledge of CAPA methodology, audit readiness, and basic compliance risk assessment.
• Confidence in reviewing promotional materials for alignment with approved claims, safety statements, and regulatory expectations.
• Strong proficiency in Microsoft Office, documentation control, and structured trackers.

Required SkillsThe successful candidate should demonstrate strong clarity in communication, accountability, integrity, collaboration, resilience, relationship-building, stakeholder management and practical problem-solving, in line with NCH Culture DNA.

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