The Pharmacovigilance & Regulatory Affairs Officer plays a critical role in ensuring the company’s products meet all UAE regulatory and pharmacovigilance requirements, while supporting patient safety, product quality, and regulatory compliance across the full product life cycle.
The role serves as the local pharmacovigilance and regulatory focal point, coordinating safety reporting, regulatory submissions, and compliance activities with Emirates Drug Establishment, Dubai Municipality, principal companies, and internal stakeholders. Operating within a matrix governance model, the Officer supports quality assurance, batch release, medical information, and promotional review processes by providing regulatory and safety oversight, while final ownership and approvals remain with designated functions.
Roles and Responsibilities
Pharmacovigilance Governance & Licensing
- 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.
Adverse Event Management & Safety Reporting
- 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.
SOPs, Safety Documentation & Regulatory Intelligence
- 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.
Training, Awareness & Internal Compliance
- 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.
Audits, Inspections & CAPA Management
- 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.
Regulatory Affairs Submissions & Lifecycle Management
- 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.
Label, Leaflet & Dossier Review
- 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.
Quality, Batch Release, Medical Information & Promotional Review Support
- 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.
Reporting, Stakeholder Management & Governance
- 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.
Qualifications & Skills
Education & Experience
- 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.
Technical & Functional Skills
- Strong 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 Skills
The 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.
Equal Opportunity Statement
New Country Healthcare is committed to creating a diverse, inclusive and respectful workplace where everyone has an equal opportunity to contribute, grow and succeed. We welcome applications from qualified candidates of all backgrounds and make employment decisions based on skills, experience, merit and business needs.
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