Pharmacovigilance Manager
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
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
