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 the monitoring, assessment, documentation, and reporting of medicine and pharmaceutical product safety information. This role focuses on reviewing adverse event reports, evaluating safety data, maintaining pharmacovigilance records, supporting signal detection activities, and coordinating safety compliance processes in accordance with applicable UAE and international regulatory requirements.

The successful candidate will work remotely with medical, regulatory affairs, clinical, quality assurance, and pharmaceutical operations teams to support patient safety initiatives and strengthen pharmacovigilance systems.

Key Responsibilities

• Review and assess incoming adverse event reports, individual case safety reports (ICSRs), and product safety complaints.
• Evaluate the completeness, consistency, and quality of safety information received from healthcare professionals, patients, clinical studies, and other sources.
• Support adverse event case processing, including data entry, coding, narrative preparation, and follow-up documentation.
• Review serious and non-serious adverse event records and identify cases requiring escalation or additional information.
• Support the assessment of seriousness, expectedness, and causality using approved pharmacovigilance procedures and documented criteria.
• Conduct literature surveillance to identify relevant published safety information concerning pharmaceutical products.
• Assist with signal detection, safety trend analysis, and evaluation of potential emerging product risks.
• Review periodic safety reports, risk management documentation, and product safety summaries.
• Support the preparation and quality review of Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs), where applicable.
• Monitor pharmacovigilance case timelines and help maintain compliance with applicable reporting requirements.
• Maintain accurate safety databases, case trackers, audit trails, and electronic documentation.
• Support reconciliation activities between pharmacovigilance, clinical, medical information, and quality systems.
• Review safety-related standard operating procedures (SOPs), work instructions, and process documentation.
• Assist with pharmacovigilance audits, inspection readiness, deviation reviews, and corrective and preventive action (CAPA) tracking.
• Coordinate remotely with regulatory affairs teams, safety vendors, clinical research organizations, and other stakeholders.
• Identify recurring documentation issues and recommend improvements to case processing quality and operational efficiency.
• Monitor relevant regulatory updates and contribute to internal pharmacovigilance compliance guidance.

Qualifications and Experience

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Medicine, Life Sciences, Nursing, or a related discipline.
• Significant professional experience in pharmacovigilance, drug safety, adverse event reporting, or pharmaceutical regulatory affairs.
• Strong understanding of pharmacovigilance principles, Good Pharmacovigilance Practices (GVP), and applicable UAE and international safety reporting requirements.
• Experience with adverse event case processing, safety database management, medical coding, and case quality review.
• Familiarity with MedDRA terminology, WHO Drug Dictionary, and pharmacovigilance reporting standards.
• Understanding of ICH guidelines, including relevant safety reporting and risk management requirements.
• Experience supporting signal detection, literature monitoring, aggregate safety reporting, and risk management documentation.
• Knowledge of pharmacovigilance systems, electronic case management platforms, and document management tools.
• Strong analytical, documentation, and data interpretation skills.
• Excellent written communication skills, particularly in preparing safety narratives and technical reports.
• High attention to detail and ability to manage confidential patient and safety information.
• Ability to coordinate with multidisciplinary teams and manage reporting deadlines in a fully remote environment.
• Professional certifications or additional training in pharmacovigilance, drug safety, clinical research, or regulatory affairs are advantageous.

What We Offer

• A 100% remote working arrangement from home.
• Competitive compensation aligned with qualifications and professional experience.
• Opportunities to contribute to medicine safety monitoring and patient protection initiatives.
• Exposure to international pharmacovigilance standards, safety databases, and regulatory processes.
• Professional development in drug safety, regulatory compliance, and risk management.
• Collaborative working environment with pharmaceutical, clinical, medical, and regulatory professionals.

How to Apply

Interested candidates should submit an updated CV highlighting relevant pharmacovigilance experience, adverse event case processing, safety reporting, regulatory knowledge, and relevant professional training or certifications.

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

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

Important Role Scope: This is a fully remote pharmacovigilance documentation, safety data review, analytical support, and regulatory coordination position. Physical clinical examinations, patient assessments, laboratory investigations, and clinical interventions must be performed by appropriately qualified local healthcare professionals. Clinical causality determinations, medical judgments, formal safety certifications, regulatory submissions, statutory reporting, and final pharmacovigilance sign-offs must be completed by appropriately authorized medical, regulatory, or pharmacovigilance professionals.