Senior Pharmacovigilance Specialist

The Valuation School; United Arab Emirates; Remote; AED 240,000 - 300,000; Full time

Job summary

The Valuation School is seeking a Senior Pharmacovigilance Specialist to join a fully remote UAE role. You will oversee adverse event reporting, ICSR validation, and safety data quality across global collaborations while ensuring regulatory compliance.

The position emphasizes expert medical writing, literature review, and cross-functional coordination in a fast-paced, fully remote setting. Ideal candidates have strong PV background, MedDRA proficiency, and experience with PSURs, PBRERs, and

Qualifications

• Bachelor's degree or higher in a related field.
• Significant professional experience in pharmacovigilance or drug safety.
• Experience reviewing and documenting ICSRs.
• Knowledge of seriousness, expectedness, causality and medical coding terminology.
• Familiarity with UAE regulatory requirements and GVP.

Responsibilities

• Review and process adverse event reports and other safety information.
• Support ICSR preparation, validation, and quality review.
• Assess completeness and accuracy of case documentation.
• Review narratives, terminology, and product information.
• Support causality, seriousness and expectedness assessments.
• Coordinate follow-up to obtain missing information.
• Monitor safety data for data quality issues and duplicates.
• Assist with PSURs, PBRERs, DSURs and safety documents.
• Support signal detection through trend analysis and database review.
• Review literature for ADR information and safety evidence.
• Maintain PV documentation and audit-ready files.
• Support SOP maintenance and PV systems.
• Coordinate with regulatory, QA, and clinical teams on safety matters.
• Assist PV audits and inspections with documentation and evidence.

Skills

Pharmacovigilance

ICSR processing

MedDRA coding

Risk assessment

Regulatory writing

Remote teamwork

Education

Bachelor's degree in Pharmacy/Pharmacology/Medicine/Life Sciences

Tools

Pharmacovigilance databases

MedDRA

Job description

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

The 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 Responsibilities

• Review 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 Experience

• Bachelor'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 Offer

• Fully 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.