Senior Pharmacovigilance Scientist

Job Summary

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

Key responsibilities

• Direct the planning, preparation, writing, and review of aggregate reports and safety assessment documents
• Organize and manage liaison activities with affiliates and internal partners regarding product safety
• Perform data analysis for signal detection and prepare presentations on safety issues for decision-making bodies

Required qualifications

• Doctorate degree and 2 years of related experience, or Master's degree and 4 years, or Bachelor's degree and 6 years, or Associate's degree and 10 years, or High school diploma/GED and 12 years of related experience
• Experience in a biotech or pharmaceutical setting, preferably with clinical/medical research experience
• 2 years of managerial experience directly managing people or leading teams
• Strong background in pharmacovigilance and safety assessment processes
• Experience in preparing regulatory submissions and risk management plans