Senior Pharmacovigilance Specialist

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

We are seeking an experienced Senior Pharmacovigilance Specialist to support drug safety surveillance, adverse event case review, safety data analysis, risk management documentation, and pharmacovigilance compliance activities. The role focuses on evaluating reported adverse events, reviewing individual case safety reports, monitoring emerging safety signals, maintaining accurate safety records, and coordinating pharmacovigilance activities across clinical, regulatory, medical, and quality teams.

The ideal candidate will have a strong background in pharmacovigilance, pharmaceutical safety operations, adverse event processing, and relevant regulatory requirements. This is a fully remote position centered on digital case review, safety data analysis, technical documentation, and virtual coordination.

Key Responsibilities

• Review and assess adverse event reports received from healthcare professionals, patients, clinical studies, literature sources, and other approved reporting channels.
• Support the processing and quality review of Individual Case Safety Reports (ICSRs).
• Evaluate case documentation for completeness, consistency, accuracy, and appropriate follow-up requirements.
• Review adverse event narratives, medical terminology, coding accuracy, and relevant supporting information.
• Analyze safety data to identify potential trends, unusual reporting patterns, and emerging safety concerns.
• Support signal detection, validation, evaluation, and documentation activities.
• Review aggregate safety reports and periodic safety update documentation, including PSURs and PBRERs.
• Assist in maintaining Risk Management Plans (RMPs) and related pharmacovigilance documentation.
• Monitor relevant scientific literature for published information concerning medicinal product safety.
• Coordinate follow-up requests for missing or incomplete safety information with authorized local teams and reporting partners.
• Review pharmacovigilance agreements, safety data exchange provisions, and relevant procedural documentation.
• Support reconciliation activities between safety databases, clinical trial systems, medical information records, and other approved sources.
• Monitor case processing timelines, regulatory reporting schedules, and pharmacovigilance performance indicators.
• Review deviations, quality events, audit findings, and corrective and preventive action (CAPA) documentation.
• Support the preparation and review of standard operating procedures, work instructions, and pharmacovigilance training materials.
• Coordinate remotely with medical, clinical operations, regulatory affairs, quality assurance, and drug safety teams.
• Prepare safety summaries, case review reports, trend analyses, and management dashboards.
• Monitor changes in pharmacovigilance regulations, safety guidance, and relevant international requirements.
• Support inspection and audit readiness through accurate digital records, traceability, and controlled documentation.
• Recommend improvements to case processing quality, safety data integrity, and pharmacovigilance workflows.

Qualifications and Experience

• Bachelor's or Master's degree in Pharmacy, Pharmacology, Medicine, Life Sciences, Biomedical Sciences, Nursing, or a related discipline.
• Typically 7–10 years of relevant experience in pharmacovigilance, drug safety, pharmaceutical quality, or clinical safety operations.
• Strong understanding of pharmacovigilance principles and adverse event reporting processes.
• Experience reviewing ICSRs, adverse event narratives, safety case documentation, and follow-up information.
• Knowledge of MedDRA terminology and safety data coding principles.
• Familiarity with signal detection, safety surveillance, risk management, and aggregate safety reporting.
• Understanding of Good Pharmacovigilance Practices (GVP), ICH guidelines, and applicable UAE pharmacovigilance requirements.
• Knowledge of relevant international regulatory frameworks, including applicable requirements of the UAE, EU, and other major regulatory jurisdictions.
• Experience using pharmacovigilance databases and safety management platforms.
• Familiarity with PSUR/PBRER preparation, RMP documentation, and safety reconciliation processes.
• Strong analytical skills and ability to interpret complex safety information.
• Excellent technical writing, documentation, and reporting abilities.
• Strong attention to detail and understanding of data privacy and confidentiality requirements.
• Ability to coordinate with multidisciplinary teams and manage competing deadlines in a fully remote environment.
• Relevant certifications or postgraduate qualifications in pharmacovigilance, clinical research, or pharmaceutical safety are advantageous.

What We Offer

• 100% remote working arrangement from home.
• Full-time opportunity in pharmaceutical safety and regulatory compliance.
• Exposure to drug safety surveillance, safety data systems, and international pharmacovigilance processes.
• Collaboration with experienced medical, regulatory, clinical, and quality professionals.
• Opportunities for professional development and specialization in drug safety management.

How to Apply

Interested candidates should submit an updated CV highlighting their pharmacovigilance experience, adverse event case processing expertise, safety database knowledge, regulatory reporting exposure, and relevant professional qualifications.

Application Subject: Application – Senior Pharmacovigilance Specialist (UAE Remote)

Candidates should confirm applicable employment arrangements, residency requirements, and work authorization before accepting an offer.

• Remote Work Scope: This position is limited to remote pharmacovigilance case review, safety data analysis, literature surveillance, digital documentation, risk management support, and regulatory coordination. Physical clinical examinations, patient assessments, laboratory investigations, medical procedures, and clinical interventions must be performed by qualified local healthcare professionals. Clinical causality determinations requiring medical judgment, patient treatment decisions, formal safety certifications, regulatory submissions, statutory adverse event reporting, and final medical or pharmacovigilance sign-offs must be completed or approved by appropriately licensed, designated, or authorized professionals in accordance with applicable regulations.