Drug Safety Officer

Key Responsibilities

• Collect Safety Data: Receive, document and organise reports of adverse drug reactions or safety concerns from various sources.
• Assess & Report Events: Evaluate safety information and submit accurate adverse event reports to regulators within required deadlines.
• Maintain Safety Records: Keep up‑to‑date safety documentation, safety databases, and master files for all products under supervision.
• Risk Analysis: Support or conduct risk assessments and signal detection to inform risk‑benefit decisions.
• Regulatory Compliance: Ensure all drug safety activities meet UAE MoHAP and Emirates Drug Establishment pharmacovigilance standards.
• Cross‑Team Collaboration: Work with regulatory, medical affairs, quality and other teams to resolve safety issues and prepare reports.
• Support Audits & Training: Assist in inspections, audits and internal training on safety reporting and compliance processes.

Requirements

• Experience: 3–7 years in pharmacovigilance, drug safety, or related life‑science roles.
• Education: Bachelor’s degree in Pharmacy, Medicine, Life Sciences, or related field.
• Technical Competence: Skilled in safety database use, MedDRA coding, and adverse event processing.
• Project Controls: Able to manage reporting timelines and regulatory deliverables reliably.
• Leadership: Can guide safety practices, advise teams, and maintain strong safety governance.
• Commercial Acumen: Understand how safety results impact product lifecycle and regulatory strategy.