Job Title: Senior Pharmacovigilance Specialist
Location: UAE (Remote)
Employment Type: Full-Time
Level: Senior
Work Arrangement: Fully Remote, with collaboration across clinical, regulatory, and medical teams as required
About UsWe are committed to protecting patient safety through effective pharmacovigilance, robust safety monitoring, and regulatory compliance. We are seeking an experienced Senior Pharmacovigilance Specialist to oversee adverse event reporting, assess medicine safety information, maintain pharmacovigilance documentation, and support compliance with applicable UAE and international drug safety requirements.
Key Responsibilities
- * Manage pharmacovigilance activities, including the collection, assessment, documentation, and reporting of adverse events and suspected adverse drug reactions.
- Review and process individual case safety reports (ICSRs) in accordance with applicable regulatory requirements and internal procedures.
- Evaluate safety information from clinical studies, healthcare professionals, patients, scientific literature, and other relevant sources.
- Conduct medical and safety case assessments, ensuring accuracy, consistency, and completeness of reported information.
- Prepare, review, and support the submission of periodic safety reports, including Periodic Safety Update Reports (PSURs) and other applicable safety documentation.
- Monitor regulatory reporting timelines and ensure timely submission of safety reports to relevant authorities.
- Support signal detection, safety trend analysis, and risk assessment activities to identify potential medicine safety concerns.
- Maintain pharmacovigilance databases, safety records, case documentation, and audit trails.
- Collaborate with Regulatory Affairs, Medical Affairs, Clinical Operations, Quality Assurance, and external safety partners.
- Support the development and maintenance of pharmacovigilance standard operating procedures, work instructions, and compliance documentation.
- Participate in safety audits, inspections, deviation investigations, and corrective and preventive action (CAPA) activities.
- Monitor changes in pharmacovigilance regulations and industry guidance, recommending updates to internal processes.
- Provide training and guidance to colleagues on adverse event reporting, safety procedures, and regulatory obligations.
- Contribute to continuous improvement initiatives to strengthen case processing quality, reporting efficiency, and patient safety.
Qualifications and Experience
- * Bachelor's degree in Pharmacy, Medicine, Life Sciences, Nursing, or another relevant healthcare discipline.
- At least 5–8 years of experience in pharmacovigilance, drug safety, clinical safety, or pharmaceutical regulatory compliance.
- Strong understanding of adverse event reporting, ICSR processing, causality assessment, and safety documentation.
- Familiarity with UAE pharmacovigilance requirements and relevant international guidelines, including ICH and applicable GVP guidance.
- Experience preparing or reviewing PSURs, risk management documentation, and regulatory safety submissions.
- Knowledge of safety databases and pharmacovigilance systems, such as Argus Safety or comparable platforms.
- Strong analytical, scientific writing, documentation, and problem-solving skills.
- Excellent attention to detail and ability to manage multiple safety cases and reporting deadlines.
- Understanding of patient confidentiality, data integrity, and pharmacovigilance quality systems.
- Relevant certifications or postgraduate qualifications in pharmacovigilance, clinical research, or drug safety are an advantage.
- Ability to work independently and collaborate effectively with international teams in a remote environment.
Key Performance Indicators (KPIs) Case Processing Quality: Maintain accurate, complete, and consistent safety case documentation.
* Regulatory Timeliness: Submit reportable safety cases within required regulatory timelines.
* Compliance Performance: Adhere to pharmacovigilance procedures and applicable regulatory requirements.
* Data Quality: Minimize errors, missing information, and case-processing discrepancies.
* Signal Management: Support timely identification, assessment, and escalation of potential safety signals.
* Audit Readiness: Maintain complete and traceable pharmacovigilance records.
* Continuous Improvement:* Improve case-processing efficiency and reduce recurring quality issues.
What We Offer
- * Competitive compensation based on qualifications and experience.
- Fully remote working arrangements.
- Opportunities to contribute to medicine safety and patient protection initiatives.
- Professional development and continuous learning opportunities.
- A collaborative, science-driven, and patient-focused working environment.
How to ApplyInterested candidates should submit an updated CV and a brief cover letter highlighting their pharmacovigilance experience, drug safety expertise, regulatory knowledge, and relevant professional certifications.
Email Subject Line: Application – Senior Pharmacovigilance Specialist (UAE Remote)
- We welcome detail-oriented professionals who demonstrate scientific rigor, regulatory awareness, and a strong commitment to patient safety and pharmaceutical quality.
