Senior Manager, Quality Compliance - job 2 of 2

Job Summary

A company is looking for a Senior Manager in Quality Standards and Compliance within Global Patient Safety & Risk Management.

Key Responsibilities

• Oversee and maintain the Pharmacovigilance System Master File (PSMF) and collaborate with Quality Assurance
• Support pharmacovigilance audit activities and regulatory inspections in collaboration with Quality Assurance
• Develop and report compliance metrics related to Global Patient Safety and Risk Management activities

Required Qualifications

• Bachelor's degree in life sciences or related field
• Minimum of 5 years in the pharmaceutical or life sciences industry with a focus on pharmacovigilance operations
• Experience with quality management systems, specifically Veeva
• Knowledge of global pharmacovigilance regulations and guidelines
• Experience in rare diseases therapeutic area is an advantage