Senior Pharmacovigilance Specialist

We're Hiring: Senior Pharmacovigilance Specialist

Location: United Arab Emirates (Remote)

Employment Type: Full-Time

Experience Level: Senior

Work Arrangement: Fully Remote

About Us

We are a globally focused organization committed to protecting patient safety and supporting the safe, effective, and compliant use of medicines across diverse markets.

Our multidisciplinary teams collaborate across Pharmacovigilance, Clinical Development, Regulatory Affairs, Medical Affairs, Quality, Clinical Operations, Epidemiology, Data Management, and external partners to identify, assess, document, and manage emerging safety risks throughout the product lifecycle.

The Role

We are seeking an experienced Senior Pharmacovigilance Specialist to lead and support pharmacovigilance activities including individual case safety reports, safety surveillance, signal detection, aggregate reporting, medical review, safety-data analysis, regulatory submissions, and pharmacovigilance quality systems.

The ideal candidate will combine strong scientific and pharmacovigilance expertise with sound medical judgment, analytical capability, regulatory awareness, and attention to detail to ensure safety information is assessed accurately, documented appropriately, and escalated or reported within applicable requirements.

Key Responsibilities

• Manage and oversee pharmacovigilance activities across assigned products, therapeutic areas, and markets.
• Review and process individual case safety reports from spontaneous, solicited, clinical, literature, and other valid sources.
• Assess incoming safety information for case validity and minimum reporting requirements.
• Perform case triage, data entry, coding, narrative development, medical assessment, quality review, and case follow-up.
• Assess seriousness, expectedness, causality, listedness, and reportability of adverse events and adverse drug reactions.
• Review adverse events, special situations, medication errors, overdose, misuse, abuse, off-label use, occupational exposure, lack of efficacy, pregnancy, and other reportable safety scenarios.
• Ensure appropriate identification and processing of serious adverse events and expedited-reporting cases.
• Conduct medical review of individual safety cases and provide clear clinical rationale for assessments.
• Develop and review high-quality case narratives that accurately reflect the available clinical information.
• Ensure safety cases are processed within applicable regulatory and internal reporting timelines.
• Coordinate follow-up activities to obtain missing or clarifying information from reporters, investigators, healthcare professionals, patients, partners, or other sources.
• Evaluate follow-up information and update safety cases appropriately.
• Perform duplicate case searches and assess potential duplicate reports.
• Ensure accurate MedDRA coding of adverse events, medical history, indications, and other relevant medical concepts.
• Apply appropriate WHO Drug or equivalent medicinal-product coding where applicable.
• Maintain consistency and accuracy across case data, narratives, coding, assessments, and source documentation.
• Conduct quality-control reviews of safety cases and identify data-quality or process deficiencies.
• Support pharmacovigilance quality assurance activities and implement corrective actions where required.
• Conduct safety surveillance across assigned products and therapeutic areas.
• Monitor safety databases, literature, clinical data, regulatory information, and other relevant sources for emerging safety concerns.
• Conduct routine signal detection and support signal evaluation activities.
• Review potential signals identified through quantitative or qualitative safety surveillance.
• Analyze disproportionality outputs and other pharmacovigilance analytics where applicable.
• Assess trends, patterns, and changes in reported adverse events and safety profiles.
• Escalate potential new safety signals or significant changes in known risks through established processes.
• Support signal validation, prioritization, assessment, and documentation.
• Prepare safety summaries, signal assessments, trend analyses, and recommendations for further action.
• Contribute to aggregate safety reports including Periodic Safety Update Reports, Periodic Benefit-Risk Evaluation Reports, Development Safety Update Reports, and other applicable reports.
• Prepare and review sections covering adverse events, cumulative safety data, signal evaluation, benefit-risk assessment, and safety conclusions.
• Support development and maintenance of Risk Management Plans and safety specifications.
• Contribute to safety evaluation and risk-minimization activities.
• Support ongoing benefit-risk assessments throughout the product lifecycle.
• Review emerging safety information and assess potential impact on product labeling and regulatory commitments.
• Collaborate with Regulatory Affairs and Medical Affairs on safety-related regulatory submissions and responses.
• Support responses to regulatory authority requests, safety inquiries, and pharmacovigilance inspections.
• Maintain awareness of applicable pharmacovigilance legislation, guidance, and regulatory expectations across relevant jurisdictions.
• Interpret safety-reporting requirements and translate regulatory expectations into operational procedures.
• Support pharmacovigilance agreements and safety-data exchange arrangements with license partners, distributors, vendors, and other third parties.
• Monitor partner safety-data exchange performance, reporting timelines, reconciliation, and compliance with contractual obligations.
• Conduct or support reconciliation of safety information between clinical, safety, quality, medical, regulatory, and other relevant systems.
• Support safety-database reconciliation activities and investigate discrepancies.
• Review literature-monitoring outputs and assess potential individual cases and safety signals identified through published information.
• Support medical-device, combination-product, product-quality complaint, and other safety-related processes where applicable.
• Coordinate with Quality teams on product complaints, manufacturing issues, recalls, and safety events requiring cross-functional assessment.
• Support pharmacovigilance inspections, audits, vendor assessments, and compliance reviews.
• Maintain accurate documentation of safety activities, decisions, assessments, and supporting evidence.
• Ensure pharmacovigilance records are complete, traceable, secure, and inspection-ready.
• Identify deviations, procedural gaps, recurring quality issues, and process weaknesses.
• Support root-cause analysis, corrective and preventive actions, and effectiveness checks related to pharmacovigilance findings.
• Contribute to pharmacovigilance system improvements, automation, workflow optimization, and safety-data quality initiatives.
• Support validation and implementation of safety databases, case-processing tools, signal-detection solutions, and other pharmacovigilance technologies.
• Monitor key pharmacovigilance performance metrics and prepare management reports.
• Analyze case-processing volumes, turnaround times, quality indicators, reporting compliance, backlog, and emerging trends.
• Develop and maintain pharmacovigilance procedures, work instructions, templates, and training materials.
• Deliver pharmacovigilance training and provide technical guidance to junior specialists and cross-functional stakeholders.
• Mentor junior pharmacovigilance professionals and review their work for quality and regulatory compliance.
• Support continuous improvement of pharmacovigilance processes, systems, documentation, and quality standards.
• Provide senior management with timely information regarding significant safety issues, compliance risks, signal trends, and operational performance.

Key Performance Indicators

• Individual case processing timeliness
• Serious case reporting compliance
• Expedited reporting compliance
• Case-processing accuracy
• Case completeness
• Case quality-assurance pass rate
• Case narrative quality
• Medical assessment accuracy
• MedDRA coding accuracy
• Product coding accuracy
• Duplicate detection accuracy
• Follow-up completion rate
• Follow-up response rate
• Safety-database data quality
• Safety-case backlog
• Case reconciliation accuracy
• Literature-monitoring timeliness
• Literature-case identification accuracy
• Signal detection timeliness
• Signal validation completion
• Signal assessment quality
• Potential-signal escalation timeliness
• Aggregate-report submission timeliness
• Aggregate-report quality
• Risk-management-plan compliance
• Benefit-risk assessment quality
• Regulatory-request response timeliness
• Regulatory submission accuracy
• Pharmacovigilance agreement compliance
• Partner reporting compliance
• Safety-data exchange timeliness
• Vendor SLA performance
• Audit finding rate
• Inspection finding rate
• CAPA completion rate
• Deviation closure timeliness
• Pharmacovigilance SOP compliance
• Training completion
• Pharmacovigilance competency development
• System reconciliation accuracy
• Safety-database availability
• Process automation adoption
• Pharmacovigilance process efficiency
• Data-quality improvement
• Continuous-improvement implementation

Ideal Candidate

The successful candidate should have strong experience in pharmacovigilance, drug safety, clinical safety, medical safety, safety surveillance, or regulatory safety operations, preferably within a pharmaceutical, biotechnology, clinical research, or other regulated life-sciences environment.

The candidate should demonstrate:

• Strong understanding of pharmacovigilance principles and drug-safety processes.
• Proven experience managing individual case safety reports throughout the case-processing lifecycle.
• Strong knowledge of adverse-event assessment, seriousness, causality, expectedness, listedness, and reportability.
• Experience processing serious and non-serious adverse events from multiple safety sources.
• Strong understanding of special situations and medically significant safety scenarios.
• Experience with MedDRA coding and medicinal-product coding.
• Strong medical and scientific understanding of adverse events and clinical safety information.