Senior Pharmacovigilance Specialist

Job Summary

To support pharmacovigilance efforts, the full-time Senior Pharmacovigilance Specialist will oversee daily case processing of adverse event cases, perform follow-up activities, and mentor less experienced staff while working remotely with potential hybrid collaboration.

Key responsibilities

• Oversee and perform daily case processing of adverse event cases, including coding and determining seriousness and expectedness
• Create and review case narratives, providing client notifications as required for case management
• Support the development of training materials and mentor less experienced staff in pharmacovigilance practices

Required qualifications

• Bachelor's degree in life sciences is required; advanced degree, RN, RPh, PharmD, or equivalent is preferred
• Three years of related work experience in pharmacovigilance
• Intermediate knowledge of pharmacovigilance and working knowledge of PV systems such as Oracle Argus Safety or ARISg
• Ability to perform peer reviews of cases for quality, consistency, and accuracy
• Strong understanding of global safety regulations for medicines