Pharmacovigilance Manager

Job Summary

A company is looking for a Manager, Office of Safety Operations (Remote).

Key Responsibilities

• Designs and implements compliant ICSR pharmacovigilance processes and training
• Leads improvement initiatives for global clinical and post-marketing case management processes
• Manages internal audits and regulatory inspections, providing documentation and subject matter expertise

Required Qualifications

• Bachelor's Degree or equivalent in a related science field
• 5+ years of pharmaceutical industry experience, including 3 years in pharmacovigilance
• Core knowledge of global Pharmacovigilance regulations (ICH, EMA, FDA)
• Experience with health authority inspections and developing training documents
• Skilled in data interpretation and proficient in case processing procedures