Description:
We are seeking a licensed Pharmacist with strong experience in Pharmacovigilance (PV), Regulatory Affairs, and UAE healthcare compliance. The successful candidate will be responsible for establishing and maintaining all PV and regulatory frameworks required in the UAE, ensuring ongoing compliance with MOHAP, EDE / DoH-Abu Dhabi, Dubai Health Authority (DHA), and other relevant authorities.
Key Responsibilities
Pharmacovigilance (PV)
- Develop, implement, and maintain a compliant UAE Pharmacovigilance System.
- Serve as the primary contact for PV-related communication with MOHAP and other authorities.
- Ensure timely reporting of Individual Case Safety Reports (ICSRs), safety issues, and periodic safety reports.
- Maintain PV documentation including SOPs, PV system master files, and safety records.
- Coordinate safety data collection, assessment, and compliance with UAE guidelines.
Regulatory Affairs & Licensing
- Lead the full process to secure the Pharmaceutical Consulting Officer licence with EDE and MOHAP.
- Manage company and pharmacist licensing requirements, renewals, and regulatory documentation.
- Prepare, submit, and follow up on regulatory submissions, variations, renewals, notifications, and approvals.
- Ensure compliance with UAE regulations regarding pharmaceutical activities, advertising, promotion, product safety, and healthcare consulting.
- Liaise with governmental authorities (MOHAP, DHA, DoH, EDE) as needed.
Compliance & Quality
- Monitor regulatory updates and ensure the company is aligned with UAE laws, including Good Pharmacovigilance Practice (GVP) and Good Regulatory Practice (GRP).
- Develop internal policies for regulatory compliance and inspection readiness.
- Perform internal audits related to PV and regulatory operations.
- Conduct training for staff and partners on regulatory and PV requirements.
Qualifications & Experience
- Master’s degree in Pharmacy (BPharm) or higher.
- Eligibility for UAE Pharmacist licence (MOH/DHA/DoH).
- 3–5+ years of experience in Pharmacovigilance and Regulatory Affairs within the UAE or GCC.
- Strong knowledge of UAE regulatory procedures, including MOHAP and EDE licensing pathways.
- Experience with PV systems, safety reporting, and regulatory submissions.
- Excellent communication skills in English and Arabic.
- High attention to detail, strong documentation skills, and the ability to work independently in a part-time setting.