Pharmacovigilance Specialist

Position Summary

The Pharmacovigilance Specialist is responsible for case processing and/or quality control activities related to clinical trial Individual Case Safety Reports (ICSRs) and post-market safety cases. This role supports timely and compliant safety reporting activities in accordance with global pharmacovigilance regulations and internal procedures.

Key Responsibilities

• Perform triage, intake, case entry, and quality control review of ICSRs originating from sponsored clinical studies and other assigned sources
• Process safety cases within applicable timelines to support compliant regulatory reporting
• Draft case narratives, perform MedDRA coding, and prepare follow-up queries as needed
• Communicate event notifications to internal stakeholders
• Conduct retrospective quality checks on completed cases to ensure accuracy and compliance
• Independently manage assigned workload, including coverage considerations for weekends and holidays
• Collaborate with Data Management teams to review and resolve reconciliation issues between clinical and safety databases
• Support investigations related to delayed regulatory reporting of clinical trial cases
• Maintain compliance with global and local pharmacovigilance regulations, guidelines, and internal procedures

Required Qualifications

• Bachelor’s degree in Science, Healthcare, or related field
• Minimum 4 years of pharmacovigilance experience
• Experience processing ICSRs within safety database systems such as Argus, ArisG, and/or Veeva
• Understanding of global safety reporting regulations and guidelines, including FDA, ICH, and EU pharmacovigilance requirements
• Strong knowledge of medical terminology and clinical concepts
• Excellent written and verbal communication skills
• Proficiency with Microsoft Office applications including Word, Excel, PowerPoint, and Outlook
• Strong organizational skills and ability to manage multiple priorities in a deadline-driven environment