Senior Pharmacovigilance Scientist

Job Summary

To support the Benefit Risk group, the full-time Senior Pharmacovigilance Safety Scientist will manage daily operational activities, author and review aggregate reports and risk management plans, and ensure quality standards are upheld while collaborating with team members and clients.

Key responsibilities

• Author and quality review of aggregate reports (PSURs/PBRERs, PADERs) and risk management plans (RMPs)
• Lead training and mentoring of team members while ensuring compliance with regulatory requirements
• Conduct literature searches and validity checks for aggregate reports, and manage relevant process trackers

Required qualifications

• Bachelor's or Master's Degree in Pharmacy, Nursing, Life Science, or a related field
• 4+ years of experience in Pharmacovigilance with a focus on Risk Management Plans
• Experience in authoring and reviewing aggregate reports and risk management plans
• Knowledge of signal detection methodologies and regulatory safety variation processes
• Experience in presenting metrics and leading discussions about quality with clients