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 project management, operational excellence, risk management, and collaborative business practices. Our organization also recognizes the importance of pharmaceutical safety, regulatory compliance, and effective health and safety oversight in supporting the well-being of employees, contractors, and other stakeholders.

Our teams collaborate across Project Management, Construction, Engineering, Procurement, Commercial, Finance, Human Resources, Occupational Health, Medical Services, Legal, Compliance, Quality Assurance, Information Technology, Consultants, Contractors, Suppliers, and Executive Leadership.
The Role
We are seeking an experienced Senior Pharmacovigilance Specialist to support the identification, assessment, monitoring, documentation, and prevention of adverse effects and other safety-related concerns associated with medicinal products.

The successful candidate will provide specialist expertise in drug safety surveillance, adverse event reporting, individual case safety report (ICSR) processing, signal detection, risk management, and regulatory compliance.

This position requires strong scientific knowledge, attention to detail, sound clinical judgment, and the ability to interpret safety information in accordance with applicable pharmacovigilance requirements. The specialist will collaborate with medical, regulatory, quality, clinical research, and compliance teams to ensure that safety information is accurately evaluated, appropriately reported, and effectively communicated.
Key ResponsibilitiesPharmacovigilance Operations and Drug Safety Surveillance

• Support and oversee pharmacovigilance activities throughout the medicinal product lifecycle, including clinical development and post-marketing surveillance, as applicable.
• Monitor the safety profiles of medicinal products and identify emerging concerns relating to adverse reactions, medication errors, product misuse, overdose, and other safety events.
• Maintain effective processes for collecting, documenting, evaluating, and communicating medicinal product safety information.
• Review safety information received from healthcare professionals, patients, clinical investigators, literature sources, business partners, and other relevant channels.
• Ensure pharmacovigilance activities are conducted in accordance with applicable regulatory requirements, approved procedures, and Good Pharmacovigilance Practices (GVP).
• Identify potential safety issues and ensure appropriate escalation to designated medical safety and regulatory personnel.
• Support the maintenance and continuous improvement of pharmacovigilance systems and operational procedures.
• Contribute to the development of safety surveillance strategies appropriate to the products and markets under responsibility.

Adverse Event and Individual Case Safety Report Management

• Receive, review, and process reports of suspected adverse reactions and other reportable safety events.
• Assess incoming safety information to determine whether it meets the criteria for a valid individual case safety report.
• Verify the availability of essential case information, including an identifiable patient, an identifiable reporter, a suspected medicinal product, and a suspected adverse reaction.
• Create, maintain, and update individual case safety reports in approved pharmacovigilance databases.
• Review patient demographics, medical history, medicinal product details, dosage, treatment dates, event descriptions, and relevant clinical information.
• Assess case completeness, consistency, seriousness, expectedness, and reportability in accordance with applicable requirements.
• Identify missing information, conflicting data, duplicate reports, and documentation deficiencies.
• Conduct appropriate follow-up with reporters or relevant stakeholders to obtain additional clinical and safety information.
• Maintain accurate case narratives and ensure that relevant medical information is captured clearly and objectively.
• Apply appropriate medical coding using recognized terminology, such as the Medical Dictionary for Regulatory Activities (MedDRA), where applicable.
• Support case prioritization, quality review, reconciliation, and timely processing.
• Ensure case documentation and processing decisions are supported by appropriate evidence and audit trails.

Serious Adverse Event and Regulatory Reporting

• Assess suspected adverse reactions for seriousness and identify events requiring expedited regulatory reporting.
• Evaluate reportability in accordance with applicable regional requirements, product authorizations, and pharmacovigilance procedures.
• Monitor regulatory reporting timelines and ensure cases are processed and submitted within required deadlines.
• Prepare and quality-check safety reports for submission to relevant regulatory authorities.
• Support the preparation and submission of applicable electronic safety reports, including E2B-compatible ICSR submissions.
• Coordinate with regulatory affairs teams to confirm reporting requirements across relevant jurisdictions.
• Monitor submission acknowledgments, validation outcomes, rejected reports, and follow-up requirements.
• Investigate reporting discrepancies and coordinate appropriate corrections or resubmissions.
• Maintain records of regulatory submissions, acknowledgments, case status, and reporting compliance.
• Escalate potential reporting delays, serious safety concerns, and compliance deviations to authorized personnel.
• Support reconciliation of safety information received from clinical research, medical information, quality, and commercial functions.

Medical Review and Safety Assessment

• Conduct detailed reviews of adverse event reports and relevant clinical information.
• Evaluate the relationship between reported events and suspected medicinal products using established medical assessment principles.
• Review the timing of exposure, event onset, clinical course, concomitant medications, underlying conditions, and available laboratory or diagnostic findings.
• Assess the plausibility and clinical significance of reported adverse reactions.
• Identify relevant alternative explanations, including disease progression, concurrent treatment, and other potential contributing factors.
• Support the assessment of seriousness, severity, expectedness, and potential impact on the product's benefit-risk profile.
• Identify cases requiring additional medical review or escalation to qualified medical safety personnel.
• Prepare clear, scientifically accurate summaries of safety findings.
• Ensure safety assessments are objective, appropriately documented, and consistent with applicable procedures.
• Collaborate with medical experts to resolve complex clinical safety questions.

Signal Detection and Safety Risk Evaluation

• Review pharmacovigilance data for potential signals of new, changing, or increased medicinal product risks.
• Analyze individual case reports, aggregate safety data, clinical findings, and relevant literature.
• Identify unusual reporting patterns, emerging adverse reactions, and potential safety trends.
• Support quantitative and qualitative signal detection activities using approved methodologies and tools.
• Evaluate potential signals in the context of available clinical, epidemiological, and pharmacological evidence.
• Assist with signal validation, prioritization, assessment, and documentation.
• Prepare signal evaluation summaries and contribute to safety review meetings.
• Coordinate with medical, regulatory, and quality teams regarding potential safety concerns.
• Support the development and implementation of appropriate risk minimization measures.
• Monitor the effectiveness of risk mitigation activities and identify opportunities for further action.
• Maintain clear documentation of signal assessments, decisions, and follow-up activities.

Periodic Safety Reports and Risk Management

• Support the preparation, review, and submission of periodic safety reports, including Periodic Safety Update Reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs), as applicable.
• Collect and reconcile safety information from clinical studies, spontaneous reports, literature, and other relevant sources.
• Assist with the evaluation of cumulative safety data and changes in the medicinal product's benefit-risk profile.
• Prepare relevant safety summaries, case analyses, and supporting documentation.
• Contribute to the development, maintenance, and review of Risk Management Plans (RMPs).
• Support the identification of important identified risks, important potential risks, and missing information.
• Assist with the evaluation of additional risk minimization measures and their implementation.
• Review safety information for consistency with product labeling, approved prescribing information, and relevant regulatory commitments.
• Coordinate with regulatory affairs and medical teams regarding safety-related product information updates.
• Track periodic reporting obligations, submission deadlines, and outstanding safety commitments.
• Support the implementation of appropriate pharmacovigilance activities for newly authorized or updated medicinal products.