Senior Manager, PV Quality Assurance

Job Summary

A company is looking for a Senior Manager, Global Pharmacovigilance (PV) Quality Assurance.

Key Responsibilities

• Provide quality oversight of the global pharmacovigilance system and ensure compliance with GVP regulations
• Support the execution of global auditing processes and determine adequacy of root cause analyses and CAPAs
• Develop and maintain processes for quality audit execution and provide QA metrics for oversight

Required Qualifications and Education

• University degree in life sciences or equivalent qualification/experience
• Extensive experience in the pharmaceutical industry in a quality or compliance function
• Preferred audit skills and experience conducting GVP audits
• Understanding of international GVP regulations and FDA PV requirements
• Experience supporting Health Agency inspections