Senior Pharmacovigilance Scientist

Job Summary

Working remotely in a full-time capacity, the Senior Pharmacovigilance Scientist will manage safety assessment activities, oversee clinical trial safety, and direct the preparation of aggregate reports while collaborating with cross-functional teams.

Key responsibilities

• Direct the planning, writing, and review of aggregate safety reports and liaise with internal partners regarding product safety
• Evaluate safety signals through data analysis and author Safety Assessment Reports in collaboration with the Global Safety Organization
• Support regulatory activities related to new drug applications and maintain inspection readiness for Health Authority inspections

Required qualifications

• Doctorate degree with 2 years, Master's degree with 4 years, Bachelor's degree with 6 years, Associate's degree with 10 years, or High school diploma/GED with 12 years of industry pharmacovigilance experience
• Experience in signal detection, evaluation, and management
• Knowledge of literature surveillance and source document review
• Experience in aggregate data analysis and interpretation
• Understanding of qualitative and quantitative safety data analysis methods