Pharmacovigilance Safety Scientist

Job Summary

A company is looking for a Pharmacovigilance Safety Scientist.

Key Responsibilities

• Author aggregate reports (PSURs/PBRERs, PADERs, etc.) for submission to health authorities
• Develop Risk Management Plans (RMPs) and Signal Management Reports as part of pharmacovigilance activities
• Perform literature searches and validate data for aggregate reports and provide support for high-priority ad-hoc activities

Required Qualifications

• Bachelor's or master's degree in pharmacy, nursing, life science, or a related field
• 2+ years of experience in pharmacovigilance, focusing on medical writing, literature search, or signal detection
• Experience in compiling metrics and participating in quality discussions
• Knowledge of ICH-GCP, FDA, EMA, and other global regulations related to pharmacovigilance
• Proficiency in computer skills, including MS Office applications