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 drug reactions and other safety-related information. The successful candidate will help ensure the safety of pharmaceutical products by reviewing individual case safety reports, evaluating safety signals, maintaining pharmacovigilance records, and supporting compliance with applicable regulatory requirements. This position is fully remote and focuses on safety data analysis, case processing oversight, medical documentation review, and regulatory coordination.
Key Responsibilities

• Manage and oversee pharmacovigilance activities for assigned pharmaceutical products and therapeutic areas.
• Review and process individual case safety reports (ICSRs) involving suspected adverse drug reactions.
• Assess adverse event reports received from healthcare professionals, patients, clinical studies, and other sources.
• Evaluate case validity, seriousness, expectedness, and causality in accordance with established procedures.
• Review medical records and supporting documentation to ensure accurate safety case assessment.
• Ensure pharmacovigilance cases are processed within applicable regulatory reporting timelines.
• Monitor and coordinate the collection of missing information and follow-up details for adverse event cases.
• Perform quality checks on safety case narratives, coding, and data entry.
• Review safety data using MedDRA terminology and relevant pharmacovigilance databases.
• Support signal detection activities and evaluate potential emerging safety concerns.
• Conduct literature screening to identify relevant published safety information.
• Assist with the preparation and review of Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs).
• Contribute to Risk Management Plans (RMPs) and other product safety documentation.
• Monitor changes in pharmacovigilance regulations, guidelines, and reporting requirements.
• Support compliance with Good Pharmacovigilance Practices (GVP) and applicable quality standards.
• Review pharmacovigilance agreements and coordinate safety information exchange with business partners.
• Maintain accurate safety databases, case records, audit trails, and controlled documentation.
• Support pharmacovigilance audits, inspections, and corrective and preventive action activities.
• Investigate deviations, documentation gaps, and case-processing quality issues.
• Prepare pharmacovigilance performance reports and safety trend analyses.
• Provide technical guidance and training support to junior pharmacovigilance personnel.
• Collaborate with regulatory affairs, medical affairs, clinical research, and quality assurance teams.

Qualifications and Experience

• Bachelor's degree in Pharmacy, Pharmacology, Medicine, Life Sciences, Biomedical Science, or a related discipline.
• Postgraduate qualification in Pharmacovigilance, Clinical Research, Pharmaceutical Sciences, or a related field is an advantage.
• Significant experience in pharmacovigilance, drug safety, or pharmaceutical safety operations.
• Previous experience in a senior pharmacovigilance specialist, drug safety scientist, or safety case management role.
• Strong understanding of adverse event reporting and individual case safety report processing.
• Knowledge of seriousness, expectedness, causality assessment, and regulatory reporting criteria.
• Familiarity with MedDRA coding and WHO Drug terminology.
• Experience with pharmacovigilance databases and safety management systems.
• Understanding of ICH guidelines, including relevant safety reporting requirements.
• Knowledge of Good Pharmacovigilance Practices (GVP) and applicable UAE pharmaceutical regulations.
• Experience preparing or reviewing PSURs, PBRERs, DSURs, and Risk Management Plans.
• Familiarity with signal detection, safety surveillance, and benefit-risk assessment.
• Strong medical and scientific literature review capabilities.
• Excellent analytical, documentation, and report-writing skills.
• Proficiency in Microsoft Office and pharmacovigilance data management tools.
• High attention to detail and commitment to patient safety and data integrity.
• Ability to manage multiple safety cases and regulatory deadlines.
• Strong written and verbal communication skills in English.

What We Offer

• Fully remote working arrangement from an eligible location.
• Opportunity to contribute to pharmaceutical product safety and patient protection.
• Collaboration with medical, scientific, regulatory, and quality professionals.
• Professional development in pharmacovigilance systems and regulatory practices.
• Competitive compensation based on experience and qualifications.

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

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 clarification: This is a 100% remote position focused on safety data review, case processing oversight, signal evaluation, scientific documentation, reporting coordination, and pharmacovigilance quality support. Physical clinical assessments, patient examinations, sample collection, and other activities requiring direct patient contact must be performed by appropriately qualified local healthcare professionals. Official safety submissions, regulatory notifications, medical decisions, and other regulated pharmacovigilance responsibilities must be completed or authorized by appropriately qualified and designated personnel in accordance with applicable UAE requirements.