Pharmacovigilance Quality Manager
Job Summary
To drive the operational implementation of the Pharmacovigilance Quality Management System, the full-time, remote Pharmacovigilance Quality Manager will oversee GPS quality management functions, manage audit readiness, and implement training programs while ensuring compliance with regulatory requirements.
Key Responsibilities
- Coordinate and manage GVP audit and inspection activities, ensuring readiness and appropriate documentation
- Develop and implement the Pharmacovigilance training program, including procedural documents and inspection readiness training
- Monitor compliance with third-party contractual obligations and pharmacovigilance agreements, addressing any gaps or non-conformities
Required Qualifications
- Bachelor's degree in pharmacy, nursing, healthcare, or a related life-science field
- At least 10 years of experience in the pharmaceutical/biotech industry, with a minimum of 5 years in pharmacovigilance or drug safety
- Proven experience in establishing and managing pharmacovigilance quality systems and processes
- Robust knowledge of pharmacovigilance regulatory requirements and guidance documents
- Expertise in GXP quality and compliance requirements and processes
Complete Job Description
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