Senior Pharmacovigilance Specialist

Location: United Arab Emirates (Remote)

Employment Type: Full-Time

Experience Level: Mid-Level to Senior

Work Arrangement: Fully Remote

We are a construction-focused organization committed to delivering complex projects through disciplined contract management, operational excellence, and collaborative project delivery. Our distributed teams collaborate across Project Management, Construction, Engineering, Procurement, Commercial, Legal, Finance, Human Resources, Design, Quality, HSE, Consultants, Contractors, Suppliers, Logistics, Administration, Information Technology, and Executive Leadership to maintain strong governance, operational reliability, and compliance with applicable standards.

We value professionals who demonstrate analytical expertise, attention to detail, and a strong commitment to safety, quality, and regulatory compliance. Through structured risk management, effective documentation, and cross-functional collaboration, we aim to support reliable business operations and maintain high standards across all specialized functions, including healthcare and pharmaceutical safety activities where applicable.

We are seeking an experienced Senior Pharmacovigilance Specialist to oversee drug safety surveillance activities, manage adverse event information, evaluate potential safety signals, and support compliance with applicable pharmacovigilance requirements. The ideal candidate will bring strong expertise in adverse event case processing, Individual Case Safety Reports (ICSRs), signal detection, benefit-risk assessment, safety database management, and regulatory safety reporting.

This role will focus on ensuring the accurate collection, assessment, documentation, and reporting of safety information associated with medicinal products. The Senior Pharmacovigilance Specialist will collaborate with Regulatory Affairs, Medical Affairs, Clinical Research, Quality Assurance, Compliance, external safety partners, and other relevant stakeholders to maintain pharmacovigilance systems, support timely regulatory submissions, and promote patient safety in accordance with applicable United Arab Emirates requirements and relevant international guidelines.

• Lead and coordinate pharmacovigilance activities for assigned medicinal products, therapeutic areas, and safety programs.
• Receive, review, assess, and process adverse event reports from healthcare professionals, patients, clinical studies, literature, and other approved sources.
• Ensure the accurate and timely processing of Individual Case Safety Reports (ICSRs).
• Evaluate adverse event information for completeness, validity, seriousness, expectedness, and potential causal relationships.
• Apply established medical and regulatory criteria when assessing adverse drug reactions and other safety concerns.
• Review adverse event narratives to ensure clarity, accuracy, consistency, and appropriate medical terminology.
• Identify missing information and coordinate follow-up requests with reporters, investigators, healthcare professionals, and other relevant parties.
• Ensure that case documentation includes the required patient, reporter, medicinal product, and event information.
• Perform medical coding of adverse events, medical history, indications, and other relevant data using approved terminology such as MedDRA.
• Review medicinal product coding and ensure consistency with approved product information and internal coding conventions.
• Assess seriousness criteria, including death, life-threatening events, hospitalization, disability, congenital anomalies, and other medically significant outcomes.
• Support the assessment of expectedness against the applicable reference safety information.
• Coordinate expedited reporting assessments and submission timelines in accordance with applicable regulatory requirements.
• Prepare, review, and submit safety reports to relevant regulatory authorities within required timelines.
• Monitor pharmacovigilance reporting deadlines and proactively address potential delays or incomplete submissions.
• Maintain accurate case tracking records, submission confirmations, follow-up status, and reconciliation documentation.
• Support the preparation and review of Periodic Safety Update Reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs).
• Contribute to Development Safety Update Reports (DSURs) and other aggregate safety reports where applicable.
• Compile and analyze cumulative safety data to…