Manager, Safety Operations

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 improvements in 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
• Experience within the pharmaceutical industry, particularly in pharmacovigilance
• Core knowledge of global pharmacovigilance regulations (ICH, EMA, FDA)
• Experience in health authority inspections and/or audits
• Skilled in data interpretation and proficient in case processing procedures