Pharmacovigilance Operations Manager

Job Summary

A company is looking for a Pharmacovigilance Operations Manager to oversee safety reporting and vendor management.

Key Responsibilities

• Act as the US/EU local safety office and FDA/EMA point of contact for safety reporting
• Support the submission of individual case safety reports and manage vendor oversight for case intake processing
• Ensure compliance with regulatory submissions and provide training and resources to vendors

Required Qualifications

• Doctorate Degree or equivalent experience
• Master's degree with 2 years of related experience, or Bachelor's degree with 4 years of related experience
• Associate's degree with 8 years of related experience, or High school diploma/GED with 10 years of related experience
• Previous experience managing teams or projects
• Understanding of global regulatory requirements for pharmacovigilance