Dubai Pharmacovigilance Associate

Role and responsibilities

• Perform case processing and safety data entry for Individual Case Safety Reports (ICSRs)
• Review and assess adverse event reports received from clinical trials, spontaneous sources, literature and other channels
• Perform data entry, medical coding, narrative writing and case follow-up as per standard procedures
• Conduct seriousness, expectedness and causality assessments based on applicable guidelines and company procedures
• Perform MedDRA coding for adverse events and WHO Drug coding for medicinal products
• Ensure accurate and timely processing of safety cases within defined timelines
• Support quality checks and reconciliation of safety data
• Maintain proper documentation and compliance with pharmacovigilance SOPs and regulatory requirements
• Assist with safety databases such as Argus Safety and other PV systems
• Support preparation of safety reports and other pharmacovigilance-related documentation

Preferred candidate profile

• Bachelor's or Master’s degree in Pharmacy, Life Sciences, Biotechnology, Microbiology, Nursing, Medicine or a related healthcare discipline
• Freshers and candidates with relevant pharmacovigilance experience may apply
• Basic understanding of Pharmacovigilance, Drug Safety, ICSR, Adverse Events and Clinical Research
• Knowledge of MedDRA coding, WHO Drug coding and safety case processing is preferred
• Familiarity with Argus Safety or other pharmacovigilance databases is an advantage
• Good written and verbal communication skills
• Strong attention to detail and analytical skills
• Ability to understand medical terminology and review clinical information accurately
• Willingness to work within defined regulatory timelines and quality standards
• Good working knowledge of MS Office, particularly Word and Excel

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