Senior Pharmacovigilance Specialist بدوام كامل في الإمارات العربية المتحدة
التخصص
الصحة والطب
نوع الدوام
دوام كامل
الخبرة
أي مستوى
الموقع
الإمارات العربية المتحدة
وصف الوظيفة
Job Title: Senior Pharmacovigilance SpecialistLocation: United Arab Emirates (Remote)Employment Type: Full-TimeWork Arrangement: 100% Remote — Work From HomeLevel: SeniorAbout the RoleThe Senior Pharmacovigilance Specialist is responsible for supporting the monitoring, assessment, documentation, and reporting of adverse events and other safety information associated with pharmaceutical products. The role focuses on individual case safety report (ICSR) review, safety database oversight, signal detection support, benefit-risk documentation, and pharmacovigilance compliance monitoring. Working entirely remotely, the specialist collaborates with drug safety teams, medical professionals, regulatory affairs departments, clinical research organizations, and pharmaceutical companies to maintain effective drug safety surveillance and support patient protection.Key ResponsibilitiesReview and process adverse event reports, adverse drug reactions, and other product safety information received from healthcare professionals, patients, clinical studies, and literature sources.Support the preparation, validation, and quality review of individual case safety reports (ICSRs).Assess the completeness, consistency, and accuracy of adverse event case documentation.Review case narratives, medical terminology, event classifications, and relevant product information.Support the assessment of seriousness, expectedness, and causality using established pharmacovigilance procedures and applicable medical review guidance.Coordinate follow-up activities to obtain missing information and clarify incomplete safety case details.Review safety data for duplicate cases, inconsistencies, coding discrepancies, and potential data quality issues.Support the monitoring of expedited and periodic safety reporting timelines.Assist with the preparation and quality review of periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBRERs), and other safety documents.Support signal detection activities through trend analysis, safety database review, and evaluation of emerging safety concerns.Review scientific literature for relevant adverse drug reaction information and emerging product safety evidence.Maintain pharmacovigilance documentation, case records, safety tracking logs, and audit-ready electronic files.Support the review and maintenance of pharmacovigilance system master files and relevant standard operating procedures.Monitor compliance with applicable Good Pharmacovigilance Practices (GVP) and relevant UAE pharmacovigilance requirements.Coordinate with regulatory affairs, quality assurance, medical information, and clinical research teams on safety-related matters.Support pharmacovigilance audits and inspections through document preparation, evidence coordination, and corrective action tracking.Review vendor and service provider documentation relating to delegated pharmacovigilance activities.Analyze safety case processing metrics, reporting performance, backlog trends, and quality indicators.Support the development of pharmacovigilance training materials and provide guidance to junior drug safety personnel.Recommend improvements to case processing workflows, data quality controls, safety reporting procedures, and pharmacovigilance systems.Qualifications and ExperienceBachelor's degree in Pharmacy, Pharmacology, Medicine, Life Sciences, Biomedical Sciences, or a related discipline.Significant professional experience in pharmacovigilance, drug safety, pharmaceutical quality, or regulatory safety operations.Strong understanding of adverse event reporting, adverse drug reactions, and pharmacovigilance case processing.Experience reviewing and documenting individual case safety reports (ICSRs).Knowledge of seriousness, expectedness, causality assessment principles, and medical coding terminology.Familiarity with MedDRA coding and relevant pharmacovigilance databases.Understanding of ICH guidelines, Good Pharmacovigilance Practices, and applicable UAE regulatory requirements.Experience supporting PSURs, PBRERs, development safety update reports (DSURs), and other safety documentation.Knowledge of signal detection, safety surveillance, and benefit-risk evaluation methodologies.Familiarity with safety database platforms and electronic regulatory documentation systems.Understanding of expedited reporting requirements, case reconciliation, and pharmacovigilance quality management.Strong scientific writing, analytical, and data interpretation skills.Excellent attention to detail and ability to manage sensitive safety information confidentially.Strong communication and coordination skills in a multidisciplinary remote working environment.Relevant certifications or postgraduate qualifications in pharmacovigilance, clinical research, or pharmaceutical safety are advantageous.What We OfferFully remote working arrangement within the stated UAE-based role framework.Opportunity to contribute to medicine safety monitoring and patient protection.Collaboration with pharmaceutical, clinical research, medical, and regulatory professionals.Exposure to international pharmacovigilance standards, safety databases, and regulatory processes.Opportunities for professional development in drug safety and pharmaceutical regulation.How to ApplyInterested candidates should submit an updated CV highlighting their pharmacovigilance experience, ICSR processing expertise, safety database knowledge, and familiarity with relevant regulatory guidelines.Application Subject: Application – Senior Pharmacovigilance Specialist (UAE Remote)Candidates should confirm applicable employment arrangements, residency requirements, and work authorization before accepting an offer. This is a fully remote pharmacovigilance case review, safety data analysis, documentation, literature surveillance, and regulatory coordination role. Physical clinical examinations, patient assessments, laboratory investigations, and clinical interventions must be performed by qualified local healthcare professionals. Clinical causality determinations, medical judgments, formal safety certifications, regulatory submissions, statutory pharmacovigilance reporting, and final safety sign-offs must be completed or approved by appropriately licensed or authorized medical, pharmacovigilance, or regulatory professionals.
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