Senior Clinical Safety Specialist

🏗 We're Hiring: Senior Clinical Safety Specialist

📍 Location: United Arab Emirates (Remote)

🕒 Employment Type: Full-Time

💼 Experience Level: Mid-Level to Senior

🌐 Work Arrangement: Fully Remote

About Us

We are a construction-focused organization committed to delivering complex projects through disciplined contract management, commercial excellence, risk control, and collaborative project delivery. Our distributed teams collaborate across Project Management, Construction, Engineering, Procurement, Commercial, Legal, Finance, Human Resources, Design, Quality, HSE, Consultants, Contractors, Suppliers, Logistics, Administration, Information Technology, and Executive Leadership to maintain high standards of operational excellence, regulatory compliance, risk management, and business continuity.

We value structured safety management, evidence-based decision-making, accurate documentation, and proactive risk mitigation across our operations. Through strong governance, collaborative problem-solving, and continuous improvement, we aim to protect stakeholders, strengthen accountability, and maintain reliable business and project delivery.

The Role

We are seeking an experienced Senior Clinical Safety Specialist to support clinical safety oversight, patient protection, adverse event management, risk assessment, and safety compliance across clinical research and healthcare-related activities. The successful candidate will coordinate safety data review, adverse event assessment, safety signal escalation, clinical safety documentation, and compliance monitoring in accordance with applicable regulations, study protocols, and organizational procedures.

This role requires strong knowledge of clinical safety principles, pharmacovigilance, clinical trial safety reporting, risk management, and regulatory requirements. The specialist will collaborate with Clinical Operations, Medical Affairs, Drug Safety, Pharmacovigilance, Regulatory Affairs, Quality Assurance, investigators, and other stakeholders to identify potential safety concerns, support timely reporting, maintain accurate safety records, and promote the protection of clinical trial participants and patients.

Key Responsibilities

• Support clinical safety oversight activities across clinical trials, observational studies, patient support programs, and other approved clinical research activities.
• Monitor clinical safety information to identify potential risks to patients, study participants, and other relevant populations.
• Review adverse events, serious adverse events, adverse reactions, and other safety-related information received from clinical sites, investigators, healthcare professionals, and authorized reporting channels.
• Assess incoming safety information for completeness, consistency, clinical relevance, and potential impact on patient safety.
• Verify that adverse event documentation includes relevant patient details, event descriptions, product exposure information, medical history, treatment information, and outcomes.
• Support the identification and documentation of serious adverse events in accordance with applicable definitions and study-specific requirements.
• Review seriousness criteria, including death, life-threatening events, hospitalization, persistent or significant disability, congenital anomalies, and other medically significant conditions.
• Support the assessment of adverse events in relation to study protocols, investigator brochures, reference safety information, and applicable regulatory guidance.
• Identify cases requiring urgent medical review, escalation, or expedited regulatory reporting.
• Coordinate with qualified medical personnel when clinical judgment, complex causality assessment, or specialized safety interpretation is required.
• Ensure that safety-related decisions are documented clearly, consistently, and in accordance with approved procedures.
• Support the timely processing and reporting of individual case safety reports arising from clinical trials and other applicable safety data sources.
• Monitor applicable reporting timelines and escalate potential delays or compliance risks.
• Coordinate with Drug Safety and Pharmacovigilance teams to ensure that reportable cases are processed and submitted within required deadlines.
• Support the reconciliation of clinical safety information between clinical trial management systems, electronic data capture systems, pharmacovigilance databases, and other relevant repositories.
• Investigate discrepancies between clinical trial records and safety database entries and coordinate appropriate resolution.
• Review clinical safety data for missing information, inconsistent dates, duplicate reports, incomplete narratives, and other data quality concerns.
• Ensure that case records and supporting documentation remain accurate, complete, traceable, and appropriately maintained.
• Support the review of clinical safety data listings, adverse event summaries, and other safety outputs used for ongoing safety monitoring.
• Identify emerging safety trends, unusual event patterns, and potential clusters requiring further investigation.
• Escalate suspected safety signals and clinically significant patterns to the appropriate medical, pharmacovigilance, and safety governance teams.
• Assist with the evaluation of potential safety signals by collecting relevant case information, reviewing available evidence, and documenting observations.
• Support ongoing benefit-risk monitoring by providing accurate safety data and contributing to structured risk assessments.
• Assist with the identification of new or changing risks associated with investigational products, marketed products, study procedures, or clinical interventions.
• Review adverse event trends in the context of patient characteristics, treatment exposure, concomitant medications, medical history, and study-specific factors.
• Support the assessment of special safety situations, including medication errors, overdose, misuse, abuse, off-label use, pregnancy exposure, breastfeeding exposure, and lack of efficacy where relevant.
• Coordinate the documentation and escalation of safety concerns involving vulnerable populations or complex clinical circumstances.
• Support the monitoring of safety events involving pediatric participants, older adults, pregnant participants, and other populations requiring specific consideration.
• Review safety information associated with protocol deviations, treatment interruptions, dose modifications, and discontinuation of investigational products.
• Collaborate with Clinical Operations to ensure that safety-related protocol requirements are communicated and implemented consistently.
• Review study protocols, informed consent documents, investigator brochures, safety management plans, and related documentation for relevant safety requirements.
• Support the development and maintenance of clinical safety management plans, safety monitoring procedures, and study-specific safety guidance.
• Assist with identifying safety risks associated with study design, eligibility criteria, dosing regimens, monitoring schedules, and clinical procedures.
• Support the implementation of appropriate risk mitigation measures and safety monitoring activities.
• Coordinate with clinical study teams to ensure that safety assessments, reporting responsibilities, and escalation pathways are clearly defined.
• Monitor compliance with protocol-specific safety procedures and applicable clinical trial requirements.
• Support the review of eligibility criteria and relevant medical information when safety considerations require additional assessment by authorized clinical personnel.
• Assist with the review of study participant safety information to identify potential contraindications, emerging risks, or the need for further medical evaluation.
• Coordinate with investigators and clinical research sites to obtain missing safety information and clarify inconsistent case details.
• Prepare and communicate focused follow-up questions to support accurate safety assessment.