Senior Drug Safety Specialist

We're Hiring: Senior Drug Safety Specialist

Location: United Arab Emirates (Remote)

Employment Type: Full-Time

Experience Level: Senior

Work Arrangement: Fully Remote

About Us

We are a globally focused organization committed to advancing patient safety, pharmaceutical quality, regulatory compliance, and responsible healthcare across diverse markets. Our teams combine pharmacovigilance, clinical development, regulatory affairs, medical, quality, data, and scientific expertise to monitor and manage the safety of medicinal products throughout their lifecycle.

Our multidisciplinary teams work across clinical trials, post-marketing surveillance, safety reporting, signal management, risk management, regulatory submissions, and safety systems to identify emerging risks and ensure timely, scientifically sound safety decisions.

The Role

We are seeking an experienced Senior Drug Safety Specialist to support and lead pharmacovigilance activities across clinical development and post-marketing environments. The role will be responsible for safety case processing, medical review support, safety surveillance, signal detection, safety reporting, aggregate data activities, risk management, and compliance with applicable pharmacovigilance requirements.

The ideal candidate will combine strong scientific judgment, attention to detail, regulatory knowledge, and analytical capabilities to ensure potential safety information is identified, assessed, documented, escalated, and reported appropriately.

Key Responsibilities

• Lead and perform drug-safety and pharmacovigilance activities across assigned medicinal products.
• Review and process individual case safety reports from clinical trials, spontaneous sources, literature, patients, healthcare professionals, partners, and other applicable channels.
• Assess incoming safety information for validity, completeness, seriousness, expectedness, and reportability.
• Perform accurate data entry, coding, case assessment, narrative preparation, and quality review within safety databases.
• Review adverse event information and assess relevant clinical and medical details.
• Apply appropriate medical terminology and coding conventions using recognized dictionaries and classification systems.
• Support assessment of seriousness, causality, expectedness, and other applicable safety criteria.
• Identify potential serious, unexpected, or reportable safety cases and ensure timely escalation.
• Perform case follow-up activities to obtain missing or clinically relevant information.
• Draft clear, accurate, medically coherent, and regulatory-compliant case narratives.
• Review case narratives, coding, assessments, and supporting documentation for completeness and consistency.
• Ensure individual case safety reports meet applicable quality and reporting requirements.
• Monitor case-processing workflows, queues, deadlines, and reporting obligations.
• Track expedited reporting timelines and support timely submission to relevant health authorities and partners.
• Conduct quality-control reviews of safety cases and identify recurring errors or data-quality issues.
• Support reconciliation of safety information between pharmacovigilance databases and clinical, regulatory, medical, quality, or other relevant systems.
• Perform safety surveillance activities for assigned products, indications, populations, and therapeutic areas.
• Review incoming safety data to identify potential safety signals, trends, clusters, or changes in reporting patterns.
• Support signal detection and evaluation using quantitative and qualitative methods.
• Conduct medical and scientific assessments of potential safety signals.
• Contribute to signal-validation, signal-confirmation, prioritization, evaluation, and tracking activities.
• Monitor emerging safety concerns from spontaneous reports, clinical studies, scientific literature, regulatory communications, and external sources.
• Conduct targeted safety reviews and cumulative assessments as required.
• Support preparation and review of aggregate safety reports, periodic safety reports, and benefit-risk assessments.
• Contribute to Periodic Benefit-Risk Evaluation Reports and other applicable periodic safety documents.
• Support Development Safety Update Reports and other clinical-development safety reporting activities where applicable.
• Review safety sections of clinical and regulatory documents for consistency and accuracy.
• Support preparation of safety summaries, tables, listings, figures, and data analyses.
• Conduct literature surveillance for relevant safety information associated with assigned products.
• Identify potentially reportable cases and safety signals from published scientific literature.
• Document literature-search strategies, results, assessments, and follow-up actions appropriately.
• Support risk-management activities, including identification and monitoring of important identified and potential risks.
• Contribute to risk-management plans and safety specifications where applicable.
• Monitor effectiveness of risk-minimization measures and support assessment of their outcomes.
• Support preparation and maintenance of pharmacovigilance risk-management documentation.
• Review product labeling and safety information for consistency with emerging safety data.
• Support assessment of potential impacts of new safety information on product labeling.
• Collaborate with Regulatory Affairs on safety-related regulatory submissions, responses, commitments, and health-authority communications.
• Support responses to regulatory requests concerning adverse events, safety signals, benefit-risk assessments, and pharmacovigilance activities.
• Ensure safety information is consistent across regulatory submissions, clinical documents, product information, and safety databases.
• Support safety oversight of clinical trials, including review of serious adverse events and expedited safety reporting.

Key Performance Indicators

• Individual case safety report processing timeliness
• Expedited reporting compliance
• Case-processing accuracy
• Case quality-control pass rate
• Case follow-up completion rate
• Serious case processing compliance
• Case narrative quality
• Medical coding accuracy
• Case data completeness
• Duplicate case detection and prevention
• Safety database accuracy
• Safety database reconciliation accuracy
• Literature surveillance completion
• Literature case identification accuracy
• Signal detection timeliness
• Signal assessment completion
• Signal evaluation quality
• Safety trend identification
• Aggregate report delivery timeliness
• Aggregate report quality
• Benefit-risk assessment quality
• Risk-management plan completion
• Risk-minimization monitoring effectiveness
• Clinical safety reconciliation accuracy
• Regulatory submission support timeliness
• Regulatory query response timeliness
• Regulatory compliance rate
• Pharmacovigilance SOP compliance
• Safety agreement compliance
• Partner reporting compliance
• Audit finding rate
• Audit and inspection readiness
• Corrective and preventive action closure
• Pharmacovigilance deviation closure
• Data-integrity compliance
• Safety-system availability
• Safety-system data quality
• Pharmacovigilance training completion
• Training competency results
• Safety-reporting backlog
• Case turnaround time
• Quality-control cycle time
• Process improvement completion
• Automation adoption
• Pharmacovigilance operational efficiency
• Stakeholder satisfaction
• Patient-safety issue escalation effectiveness

Ideal Candidate

The successful candidate should have strong experience in drug safety, pharmacovigilance, clinical safety, medical safety, regulatory safety, or pharmaceutical safety operations, preferably within pharmaceutical, biotechnology, healthcare, clinical research, or other regulated life-science environments.

The candidate should demonstrate:

• Strong understanding of pharmacovigilance principles and drug-safety processes.
• Proven experience processing and reviewing individual case safety reports.
• Strong knowledge of adverse-event terminology, medical coding, and safety-data standards.
• Experience assessing seriousness, causality, expectedness, and reportability.
• Strong understanding of expedited safety reporting requirements and timelines.
• Experience with pharmacovigilance safety databases and case-management systems.
• Strong knowledge of safety surveillance and signal-detection principles.
• Experience supporting signal assessment and safety-trend analysis.
• Experience preparing or reviewing aggregate safety reports and benefit-risk assessments.
• Strong understanding of clinical-trial safety reporting requirements.
• Experience conducting or supporting pharmacovigilance literature surveillance.
• Knowledge of risk-management plans and risk-minimization activities.
• Strong understanding of applicable pharmacovigilance regulations and guidance, including GVP principles and relevant international requirements.