Senior Pharmacovigilance Specialist

🏗 We're Hiring: Senior Pharmacovigilance Specialist

Location: United Arab Emirates (Remote)

Employment Type: Full-Time

Experience Level: Mid-Level to Senior

Work Arrangement: Fully Remote

About Us

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.

The Role

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.

Key Responsibilities

• 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 identify emerging patterns and changes in the safety profile of medicinal products.
• Conduct routine signal detection activities using case series reviews, statistical outputs, literature findings, and other relevant safety information.
• Investigate potential safety signals and evaluate their clinical significance, strength of evidence, and potential impact on patients.
• Support signal validation, prioritization, assessment, tracking, and documentation in accordance with established procedures.
• Prepare signal assessment summaries and recommendations for review by qualified medical and safety decision-makers.
• Monitor relevant scientific literature for newly reported adverse reactions, safety concerns, and emerging evidence associated with assigned products.
• Evaluate published case reports and scientific studies for potential pharmacovigilance reporting obligations.
• Maintain documented literature search strategies, search records, review outcomes, and case identification logs.
• Coordinate literature-related safety activities with external service providers and internal medical teams.
• Support ongoing benefit-risk evaluations by integrating clinical trial findings, post-marketing safety data, literature evidence, and regulatory information.
• Identify changes in the benefit-risk profile of medicinal products and escalate material concerns through established governance channels.
• Contribute to the development and maintenance of Risk Management Plans (RMPs) and related risk minimization activities.
• Review safety-related sections of product information, patient information leaflets, and other relevant regulatory documentation.
• Support the evaluation and implementation of safety labeling changes when new risks or updated evidence are identified.
• Coordinate with Regulatory Affairs to ensure consistency between safety assessments, approved product information, and regulatory submissions.
• Assist with the preparation and maintenance of pharmacovigilance system documentation and operational procedures.
• Maintain awareness of applicable UAE pharmacovigilance requirements and relevant international standards, including ICH guidance and applicable GVP principles.
• Interpret relevant regulatory updates and assess their implications for pharmacovigilance processes and reporting obligations.
• Support compliance with applicable reporting requirements, including local timelines, submission formats, and authority-specific procedures.
• Maintain complete and accurate pharmacovigilance records to support traceability, audit readiness, and regulatory inspections.
• Ensure safety information is managed in accordance with applicable data protection, confidentiality, and information security requirements.
• Coordinate the reconciliation of safety data between pharmacovigilance systems, clinical databases, medical information records, and external partners.
• Investigate discrepancies identified during case reconciliation and ensure that corrective actions are appropriately documented.
• Support pharmacovigilance agreements with distributors, licensing partners, service providers, and other relevant organizations.
• Monitor the performance of external pharmacovigilance vendors and ensure that agreed safety responsibilities are fulfilled.
• Review vendor deliverables for completeness, accuracy, quality, and adherence to contractual and regulatory requirements.
• Support the qualification, onboarding, and periodic assessment of third-party pharmacovigilance service providers.
• Assist in maintaining oversight of local and global pharmacovigilance responsibilities across relevant business relationships.
• Contribute to the development, review, and maintenance of Standard Operating Procedures (SOPs), work instructions, and process guidance.
• Identify procedural gaps and recommend improvements to case processing, signal management, reporting, and safety documentation.
• Conduct quality control reviews of adverse event cases, aggregate reports, and other pharmacovigilance deliverables.
• Investigate deviations, errors, missed deadlines, and recurring quality issues related to safety operations.
• Support root cause analysis and the development of appropriate corrective and preventive actions (CAPAs).
• Monitor CAPA implementation and verify that corrective measures are completed and appropriately documented.