Senior Pharmacovigilance Specialist (Remote, UAE)

About the role

A fully remote, 100% work-from-home position for a Senior Pharmacovigilance Specialist based in the United Arab Emirates. The role supports drug safety monitoring, adverse event reporting, safety data assessment and pharmacovigilance compliance, covering safety case processing, medical literature review, signal detection support, safety documentation and regulatory coordination. Physical attendance or direct clinical procedures must be handled by appropriately qualified local personnel.

Key responsibilities

• Review, process and assess individual case safety reports (ICSRs) and evaluate adverse event reports for completeness, accuracy, seriousness, expectedness and potential causal relationships.
• Support collection, validation, coding and documentation of safety information from healthcare professionals, patients, clinical studies and other sources.
• Screen medical literature for adverse events and emerging safety concerns, and support signal detection, validation and benefit-risk assessment.
• Assist with preparation, review and submission coordination of periodic safety reports such as PBRERs and DSURs.
• Maintain safety databases, case narratives, source documentation and audit trails, and monitor case-processing timelines and reporting obligations.
• Collaborate with medical reviewers, regulatory affairs, clinical research and quality assurance teams, and support audits, inspections and corrective and preventive actions.
• Monitor changes in pharmacovigilance legislation and guidance, contribute to process improvement, and mentor junior staff.

Required profile

• Bachelor's degree in Pharmacy, Medicine, Life Sciences, Biomedical Sciences, Nursing or another relevant scientific discipline.
• Significant experience in pharmacovigilance, drug safety, adverse event reporting or pharmaceutical safety operations.
• Strong understanding of ICSR processing, adverse event classification and safety reporting requirements.
• Experience with medical terminology, MedDRA coding and WHO Drug coding or equivalent systems.
• Knowledge of serious adverse event assessment, signal management and benefit-risk evaluation.
• Excellent written and verbal English; additional languages are an advantage.

Required skills

• Familiarity with ICH GVP guidance and safety databases and pharmacovigilance systems.
• Understanding of quality management systems, audit readiness and controlled documentation.
• Analytical, organisational and scientific writing skills, with attention to detail.

What we offer

• A fully remote, work-from-home opportunity in pharmaceutical safety and pharmacovigilance.
• Collaboration with multidisciplinary teams across drug safety, medical affairs, clinical research and regulatory affairs.
• Professional development in pharmacovigilance systems, safety assessment and regulatory reporting.

To apply, submit an updated CV through the application form, stating the subject "Application - Senior Pharmacovigilance Specialist (UAE Remote)". Candidates should confirm employment arrangements, professional registration, UAE residency and work authorization before accepting an offer.