Pharmacovigilance Quality Manager

Job Summary

Driving the operational implementation of the Pharmacovigilance Quality Management System, the full-time remote GPS Quality Manager will oversee quality management functions, manage training programs, and ensure compliance with third-party contractual obligations.

Key responsibilities

• Coordinate and manage GVP audit and inspection activities, ensuring readiness and compliance
• Develop and implement the pharmacovigilance training program and manage procedural document activities
• Oversee the operational maintenance of pharmacovigilance agreements and monitor compliance with contractual obligations

Required qualifications

• Bachelor's degree in pharmacy, nursing, healthcare, or a related life-science field
• At least 7 years of experience in the pharmaceutical/biotech industry, with 5 years in pharmacovigilance or drug safety
• Proven experience in establishing or managing pharmacovigilance quality systems and processes
• Solid knowledge of pharmacovigilance regulatory requirements and guidance documents
• Expertise in GXP quality and compliance requirements