Clinical Safety Manager

About Us

We are a research-centric organization dedicated to safeguarding patient safety and advancing quality clinical development. Our globally distributed teams work together across multiple functions including Clinical Research, Pharmacovigilance, Medical Affairs, Regulatory Affairs, Biostatistics, Data Management, Quality Assurance, Drug Development, and Executive Leadership to proactively identify and manage clinical safety risks throughout the product lifecycle.

Role Overview

The Clinical Safety Manager will oversee clinical safety surveillance and lead activities including safety data reviews, risk assessments, medical evaluations, safety signal management, and clinical development safety processes. The role ensures accurate identification, evaluation, documentation, escalation, and integration of emerging safety information into risk management and clinical decisions.

Key Responsibilities

• Design and execute clinical safety strategies, surveillance plans, risk management frameworks, procedures, and governance processes.
• Continuously review and assess clinical safety data from trials, post-marketing sources, medical literature, reports, and registries.
• Collaborate with diverse teams such as Clinical Research, Pharmacovigilance, Medical Affairs, Regulatory, Biostatistics, Data Management, Quality Assurance, Clinical Operations, and Executive Leadership.
• Conduct or supervise medical review of adverse events, serious adverse events, special interest events, lab anomalies, vital signs, and other safety information.
• Identify, evaluate, and manage safety signals using structured detection and medical assessment methodologies.
• Lead safety-related meetings, governance forums, medical monitoring discussions, and cross-functional risk assessments.
• Create and maintain safety review and monitoring plans, safety specifications, risk assessments, and surveillance strategies.
• Analyze case safety reports, aggregate safety data, narratives, tables, and other relevant safety outputs.
• Assess causality, seriousness, expectedness, severity, temporal relationships, clinical relevance, and safety trends.
• Provide safety input for clinical protocols, investigator brochures, informed consent, statistical plans, study reports, risk plans, and regulatory documents.
• Monitor KPIs such as review timelines, case quality, signal assessments, data reconciliation, protocol deviations with safety impact, issue resolution, and regulatory reporting performance.
• Work with clinical teams to identify patient risks and formulate monitoring, mitigation, escalation, and risk management strategies.
• Oversee clinical trial safety monitoring including emerging trends, risk assessments, dose-related findings, discontinuations, deaths, and serious adverse events.
• Participate in Data Monitoring Committee (DMC), Safety Review Committee, Clinical Trial Teams and other governance activities.
• Reconcile safety data across clinical, pharmacovigilance, laboratory, electronic data capture, and other systems.
• Ensure all clinical safety activities comply with UAE regulations, ICH-GCP, pharmacovigilance standards, research regulations, ethical requirements, and international regulatory expectations.
• Assist in preparing and reviewing regulatory safety documents including DSURs, periodic safety reports, risk management files, narratives, regulatory responses, and related submissions.
• Conduct or support investigations into safety issues, protocol safety concerns, data discrepancies, unexpected events, and emerging risks.
• Promote continuous improvement through standardized review processes, quality controls, root cause analysis, risk-based monitoring, and process optimization.
• Lead digital transformation initiatives using AI-driven signal detection, natural-language processing, automated safety data review, predictive analytics, medical coding, and intelligent case triage technologies.
• Utilize systems such as Argus Safety, Veeva Vault Safety, Oracle Clinical, Medidata Rave, EDC platforms, SAS, R, Python, Power BI, Tableau, Microsoft 365, safety databases, and pharmacovigilance technologies.
• Manage budgets, external consultants, medical reviewers, pharmacovigilance service providers, safety technology platforms, and specialized vendors.
• Prepare executive-level safety reports, signal assessments, risk summaries, dashboards, clinical safety reviews, regulatory updates, benefit-risk evaluations, and strategic advice for leadership.
• Lead and mentor clinical safety specialists, medical reviewers, safety scientists, clinical research professionals, and multidisciplinary teams fostering a culture of patient safety, scientific rigor, regulatory adherence, accountability, and continuous advancement.

Requirements

• Bachelor's degree in Medicine, Pharmacy, Nursing, Life Sciences, Biomedical Sciences, Pharmacology, Clinical Research, or a related discipline.
• Advanced degrees (Medical, PharmD, Master's) or qualifications in Clinical Pharmacology, Pharmacovigilance, Clinical Research, Epidemiology, or related fields are strongly preferred.
• Certifications or formal training in pharmacovigilance, clinical research, drug safety, medical monitoring, ICH-GCP, or similar domains are advantageous.
• Minimum five years of professional experience in clinical safety, pharmacovigilance, clinical research, drug development, or related medical monitoring roles.
• At least two years experience managing clinical safety programs, surveillance activities, trial safety teams, signal management, or interdisciplinary clinical safety projects preferred.
• Deep knowledge of clinical safety surveillance, adverse event analysis, pharmacovigilance principles, signal detection, benefit-risk evaluation, clinical trial safety, medical review, and regulatory compliance.
• Experience with technologies including Argus Safety, Veeva Vault Safety, Oracle Clinical, Medidata Rave, EDC systems, SAS, R, Python, Power BI, Tableau, Microsoft 365, clinical data platforms, and safety databases.
• Familiarity with AI-powered safety signal detection, natural-language processing, predictive analytics, automated case triage, medical coding, and modern pharmacovigilance platforms is a plus.
• Excellent clinical judgment, scientific analysis, medical review skills, communication, regulatory interpretation, stakeholder engagement, project management, organization, and problem-solving abilities.
• Ability to handle multiple clinical safety initiatives balancing regulatory demands, patient safety, clinical timelines, data quality, risk management, and stakeholder interests.
• Proven capacity to work productively in remote and distributed team environments with occasional travel to meetings, investigator conferences, regulatory discussions, and industry events as necessary.

What We Offer

• Fully remote work option that facilitates collaboration with global teams across clinical safety, pharmacovigilance, clinical research, medical affairs, regulatory, quality, and data management functions.
• Competitive salary with performance-related bonuses.
• Comprehensive health and wellness benefits.
• Opportunities for professional development and leadership growth in clinical safety.
• Exposure to cutting-edge AI-driven pharmacovigilance, predictive analytics, automated signal detection, intelligent case processing, and next-gen safety technologies.
• A collaborative culture committed to patient safety, scientific excellence, regulatory integrity, innovation, quality, and ongoing improvement.
• Chance to enhance clinical development and patient protection through leadership in safety surveillance, risk evaluation, signal management, and evidence-based safety decisions.