Senior Pharmacovigilance Specialist

Job Title: Senior Pharmacovigilance Specialist
Location: United Arab Emirates (Remote)

Employment Type: Full-Time

Work Arrangement: 100% Remote — Work From Home

Level: Senior
About the Role
We are seeking an experienced and detail-oriented Senior Pharmacovigilance Specialist to support drug safety monitoring, adverse event reporting, safety data assessment, and pharmacovigilance compliance activities. The successful candidate will help ensure the ongoing safety evaluation of pharmaceutical products by reviewing safety information, coordinating case processing, monitoring regulatory requirements, and supporting risk management activities.

The ideal candidate will possess strong knowledge of pharmacovigilance regulations, Individual Case Safety Reports (ICSRs), adverse event assessment, signal detection, and safety documentation. This position is designed for fully remote work, with responsibilities performed through secure safety databases, digital documentation systems, and virtual collaboration.
Key Responsibilities

• Adverse Event Management: Receive, review, assess, and process adverse event reports from healthcare professionals, patients, clinical studies, and other approved sources.
• Individual Case Safety Reports: Oversee the preparation, validation, quality review, and submission coordination of ICSRs in accordance with applicable reporting requirements.
• Case Processing: Review case narratives, patient information, medical history, suspect products, concomitant medications, and reported adverse events for completeness and consistency.
• Medical Coding: Apply or review standardized medical terminology and medicinal product coding using recognized dictionaries such as MedDRA and WHODrug, where applicable.
• Causality and Seriousness Assessment: Support the evaluation of adverse events, including seriousness, expectedness, and causality, in accordance with approved procedures and relevant medical oversight.
• Regulatory Reporting: Coordinate expedited and periodic safety reporting activities in line with applicable regulatory timelines and reporting requirements.
• Signal Detection: Review safety data, case trends, and emerging patterns to identify potential safety signals and escalate findings for further assessment.
• Aggregate Safety Reports: Contribute to the preparation and quality review of Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs), as applicable.
• Risk Management: Support the development, implementation, and review of Risk Management Plans (RMPs) and other product safety risk minimization activities.
• Literature Surveillance: Coordinate searches and reviews of relevant scientific literature to identify reportable adverse events and emerging drug safety information.
• Safety Database Management: Maintain accurate and complete safety records in pharmacovigilance databases and ensure case documentation is traceable and audit-ready.
• Quality Assurance: Conduct case quality reviews, identify processing errors, and implement corrective and preventive actions where required.
• Standard Operating Procedures: Follow and contribute to the development of pharmacovigilance SOPs, work instructions, and quality control processes.
• Regulatory Compliance: Monitor applicable UAE pharmacovigilance requirements and relevant international guidance, including ICH and other applicable regulatory standards.
• Clinical Trial Safety: Support the review and processing of serious adverse events and suspected unexpected serious adverse reactions in clinical research, where applicable.
• Cross-Functional Collaboration: Work remotely with medical affairs, regulatory affairs, clinical operations, quality assurance, and other relevant teams to resolve safety-related issues.
• Vendor Coordination: Coordinate with pharmacovigilance service providers, partners, and affiliates to monitor case quality, reporting timelines, and contractual obligations.
• Training and Mentoring: Provide guidance to junior pharmacovigilance professionals and support training on case processing, reporting requirements, and safety procedures.
• Safety Reporting and Metrics: Prepare reports on case volumes, reporting timelines, quality findings, compliance status, and operational performance.
• Continuous Improvement: Recommend improvements to safety workflows, case processing efficiency, data quality, and pharmacovigilance compliance controls.

Qualifications and Experience

• Bachelor's degree in Pharmacy, Medicine, Life Sciences, Nursing, Biomedical Sciences, or a related healthcare discipline.
• At least 5–8 years of relevant experience in pharmacovigilance, drug safety, pharmaceutical safety operations, or a related regulated environment.
• Strong understanding of adverse event reporting, ICSR processing, case narratives, seriousness assessment, and regulatory reporting timelines.
• Familiarity with applicable UAE pharmacovigilance requirements and relevant international standards, including ICH guidelines.
• Experience preparing or reviewing safety reports, case documentation, and regulatory submissions.
• Knowledge of MedDRA coding, WHODrug, causality assessment principles, and signal detection methodologies.
• Experience using pharmacovigilance databases and safety systems such as Argus Safety or equivalent platforms.
• Understanding of PSURs/PBRERs, DSURs, Risk Management Plans, and other safety documentation is an advantage.
• Strong analytical, medical literature review, documentation, and problem-solving skills.
• Excellent written and verbal communication skills, particularly in preparing accurate case narratives and safety summaries.
• Strong attention to detail and ability to maintain data integrity across high-volume safety operations.
• Ability to prioritize multiple cases, meet strict reporting deadlines, and escalate critical safety issues appropriately.
• Familiarity with pharmacovigilance quality management systems, audits, inspections, and corrective and preventive actions.
• Relevant professional certifications or postgraduate qualifications in pharmacovigilance, clinical research, or drug safety are advantageous.
• Ability to work independently from home using secure systems while collaborating effectively with international teams.

Key Performance Indicators (KPIs)

• Case Processing Timeliness: Complete and review safety cases within established operational and regulatory deadlines.
• Reporting Compliance: Support timely and accurate submission of reportable safety information.
• Case Quality: Maintain high standards of accuracy, completeness, medical coding, and narrative quality.
• Regulatory Compliance: Ensure assigned activities follow applicable pharmacovigilance procedures and regulatory requirements.
• Signal Escalation: Identify and escalate potential safety signals and significant safety concerns promptly.
• Database Accuracy: Maintain complete, consistent, and traceable safety records.
• Audit Readiness: Support successful audits and inspections through accurate documentation and effective corrective actions.
• Workflow Efficiency: Improve case throughput while maintaining established quality standards.
• Training and Development: Support team competency and consistent application of pharmacovigilance procedures.
• Continuous Improvement: Contribute to reductions in processing errors, overdue cases, and recurring quality issues.

What We Offer

• Competitive compensation based on qualifications and relevant experience.
• 100% remote working arrangement, with responsibilities performed from home through secure digital systems.
• Opportunities to contribute to drug safety monitoring and pharmaceutical risk management activities.
• Professional development opportunities in pharmacovigilance, regulatory affairs, and drug safety.
• Exposure to international safety reporting processes and cross-functional pharmaceutical operations.
• A quality-focused working environment that values patient safety, scientific accuracy, and regulatory compliance.

How to Apply
Interested candidates should submit an updated CV highlighting their pharmacovigilance experience, safety case processing expertise, regulatory reporting knowledge, and achievements in drug safety operations.

Applicants are encouraged to include examples of safety databases used, types of safety reports handled, quality improvement initiatives, and experience meeting regulatory reporting timelines.

Email Subject Line: Application – Senior Pharmacovigilance Specialist (UAE Remote)

We welcome applications from qualified professionals who demonstrate strong drug safety expertise, analytical judgment, and a commitment to protecting patient safety through accurate and compliant pharmacovigilance practices.

• Important: Candidates should confirm applicable employment arrangements, residency requirements, and work authorization before accepting an offer.