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 adverse events and other safety information associated with pharmaceutical products. This fully remote role focuses on individual case safety report (ICSR) processing, safety database management, signal detection support, regulatory documentation, and ongoing benefit-risk monitoring. The successful candidate will help maintain robust pharmacovigilance processes, support patient safety initiatives, and ensure that safety information is handled accurately and in accordance with applicable requirements.
Key Responsibilities

• Coordinate pharmacovigilance activities across assigned pharmaceutical products and therapeutic areas.
• Receive, review, and process adverse event reports from healthcare professionals, patients, clinical studies, and other approved sources.
• Perform completeness checks and data entry for Individual Case Safety Reports (ICSRs) in validated safety databases.
• Assess reported adverse events for seriousness, expectedness, causality, and reportability in accordance with approved procedures.
• Support medical coding of adverse events, medical history, and medicinal products using recognized terminology such as MedDRA and WHODrug.
• Monitor case processing timelines and coordinate follow-up requests for missing or incomplete safety information.
• Prepare and review case narratives, safety summaries, and supporting pharmacovigilance documentation.
• Support the preparation and quality review of Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs).
• Assist with signal detection activities, including trend analysis, literature monitoring, and review of potential safety signals.
• Maintain accurate safety records, case documentation, and audit trails in accordance with internal procedures.
• Monitor relevant scientific literature and identify safety information requiring further assessment.
• Support the review and reconciliation of safety data from clinical trials, post-marketing surveillance, and other sources.
• Coordinate pharmacovigilance queries with medical, regulatory, clinical operations, and quality assurance teams.
• Assist with pharmacovigilance agreements, vendor oversight documentation, and safety data exchange processes.
• Monitor changes in applicable pharmacovigilance regulations, guidelines, and reporting requirements.
• Support internal audits, inspections, and pharmacovigilance system quality reviews by preparing relevant evidence.
• Identify process gaps, recurring case-processing errors, and opportunities to improve safety reporting quality.
• Escalate significant safety concerns, potential regulatory non-compliance, and urgent case-processing issues through established channels.

Qualifications and Experience

• Bachelor's degree in Pharmacy, Pharmacology, Pharmaceutical Sciences, Life Sciences, Medicine, or a related discipline.
• Significant experience in pharmacovigilance, drug safety, clinical safety operations, or pharmaceutical regulatory support.
• Strong understanding of pharmacovigilance principles, adverse event reporting, and post-marketing safety surveillance.
• Knowledge of ICH guidelines, including relevant Good Pharmacovigilance Practice principles and applicable regional requirements.
• Familiarity with UAE pharmaceutical regulatory requirements and international safety reporting standards.
• Experience processing ICSRs and reviewing adverse event data for completeness, consistency, and reportability.
• Working knowledge of MedDRA, WHODrug, and pharmacovigilance safety databases.
• Experience supporting PSURs, PBRERs, DSURs, risk management plans, and other safety documentation.
• Understanding of signal detection, benefit-risk evaluation, and safety data reconciliation.
• Strong analytical, scientific writing, and documentation skills.
• High attention to detail and ability to manage case-processing timelines and competing priorities.
• Proficiency in Microsoft Office and electronic document management systems.
• Ability to handle confidential patient and safety information in accordance with data protection requirements.
• Relevant pharmacovigilance or drug safety certifications are an advantage.

What We Offer

• A fully remote, work-from-home position based in the UAE.
• Competitive compensation aligned with qualifications and professional experience.
• Opportunities to contribute to medicine safety and pharmaceutical quality initiatives.
• Exposure to diverse therapeutic areas and international pharmacovigilance processes.
• Professional development opportunities in drug safety and regulatory compliance.

How to Apply
Interested candidates should submit an updated CV highlighting their pharmacovigilance experience, safety database expertise, regulatory knowledge, and relevant qualifications.

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

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

• Professional Scope: This role provides remote pharmacovigilance data review, case processing support, safety trend analysis, documentation, and regulatory coordination. Clinical diagnosis, independent medical causality determinations where reserved for qualified medical professionals, formal safety sign-offs, regulatory submissions, and legally designated pharmacovigilance responsibilities must be performed or approved by appropriately qualified and authorized professionals in the relevant jurisdiction.