Senior Pharmacovigilance Specialist

Job Title: Senior Pharmacovigilance Specialist

Location: United Arab Emirates (Remote)Employment Type: Full-TimeWork Arrangement: 100% Remote — Work From HomeLevel: SeniorAbout the RoleWe are seeking an experienced Senior Pharmacovigilance Specialist to support drug safety monitoring, adverse event reporting, safety data assessment, and pharmacovigilance compliance.

The successful candidate will contribute to the identification, evaluation, and documentation of potential safety concerns associated with medicinal products, helping ensure that safety information is processed accurately and reported within applicable regulatory timelines.This position is designed for fully remote work, with responsibilities focused on safety case processing, medical literature review, signal detection support, safety documentation, and regulatory coordination. Activities requiring physical attendance or direct clinical procedures must be handled by appropriately qualified local personnel.Key ResponsibilitiesReview, process, and assess individual case safety reports (ICSRs) involving suspected adverse reactions to medicinal products.Evaluate adverse event reports for completeness, accuracy, seriousness, expectedness, and potential causal relationships in accordance with applicable procedures.Support the collection, validation, coding, and documentation of safety information received from healthcare professionals, patients, clinical studies, and other sources.Conduct medical literature screening to identify relevant published reports of adverse events and emerging drug safety concerns.Support signal detection, signal validation, and ongoing benefit-risk assessment activities.Assist with the preparation, review, and submission coordination of periodic safety reports, including Periodic Benefit-Risk Evaluation Reports (PBRERs) and Development Safety Update Reports (DSURs), as applicable.Monitor pharmacovigilance case-processing timelines and help ensure compliance with relevant reporting obligations.Review safety data for trends, inconsistencies, duplicate reports, and potential emerging risks.Maintain accurate safety databases, case narratives, source documentation, and audit trails.Collaborate with medical reviewers, regulatory affairs teams, clinical research teams, quality assurance personnel, and other stakeholders.Support the preparation and maintenance of pharmacovigilance system documentation, including standard operating procedures, work instructions, and safety management plans.Participate in pharmacovigilance audits, inspections, and quality reviews by preparing documentation and supporting corrective and preventive action plans.Monitor relevant changes in pharmacovigilance legislation, regulatory guidance, and industry best practices.Contribute to process improvement initiatives that enhance case-processing accuracy, reporting efficiency, and overall safety oversight.Provide technical guidance and mentoring to junior pharmacovigilance staff, as appropriate.Qualifications and ExperienceBachelor's degree in Pharmacy, Medicine, Life Sciences, Biomedical Sciences, Nursing, or another relevant scientific discipline.Significant experience in pharmacovigilance, drug safety, adverse event reporting, or pharmaceutical safety operations.Strong understanding of pharmacovigilance principles, ICSR processing, adverse event classification, and safety reporting requirements.Familiarity with relevant international guidance, including ICH pharmacovigilance guidelines and Good Pharmacovigilance Practices (GVP), where applicable.Experience with medical terminology, MedDRA coding, and WHO Drug coding or equivalent medicinal product coding systems.Knowledge of serious adverse event assessment, signal management, and benefit-risk evaluation.Familiarity with safety databases and pharmacovigilance systems used for case management and regulatory reporting.Experience reviewing safety narratives, medical literature, and regulatory safety documentation.Strong analytical, organizational, and scientific writing skills, with excellent attention to detail.Ability to manage multiple safety cases and deadlines while maintaining data accuracy and confidentiality.Understanding of quality management systems, audit readiness, and controlled documentation.Excellent written and verbal English communication skills; additional languages are an advantage.Relevant pharmacovigilance, clinical research, or drug safety certifications are an advantage.What We OfferA fully remote, work-from-home opportunity in pharmaceutical safety and pharmacovigilance.Opportunities to contribute to medicine safety monitoring and regulatory compliance.Collaboration with multidisciplinary teams across drug safety, medical affairs, clinical research, and regulatory affairs.Professional development in pharmacovigilance systems, safety assessment, and regulatory reporting.A quality-focused working environment emphasizing patient safety, scientific accuracy, and continuous improvement.How to ApplyInterested candidates should submit an updated CV highlighting their pharmacovigilance experience, safety case-processing expertise, regulatory reporting knowledge, relevant qualifications, and familiarity with safety databases.Application Subject: Application – Senior Pharmacovigilance Specialist (UAE Remote)Important: Candidates should confirm applicable employment arrangements, relevant professional registration requirements, UAE residency requirements, and work authorization before accepting an offer. This position is intended to be 100% remote and focuses on digital safety data review, documentation, analysis, and regulatory coordination. Any activities requiring clinical examination, physical procedures, or on-site responsibilities must be performed by appropriately qualified and authorized local personnel.