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Accountabilities:
- Support the implementation and maintenance of a comprehensive GVP-compliant quality assurance program covering clinical trial safety and post-market pharmacovigilance processes.
- Plan, conduct, and support pharmacovigilance audits, including preparation, execution, reporting, corrective action follow-up, and closure activities.
- Support regulatory inspection readiness activities and participate in health authority inspections.
Requirements:
- Bachelor’s degree with 8+ years of relevant experience, master’s degree with 6+ years, or PhD with 3+ years for Assistant Director level; bachelor’s degree with 12+ years, master’s degree with 8+ years, or PhD with 5+ years for Associate Director level.
- Experience in GVP quality assurance, clinical trial safety, pharmacovigilance, or related pharmaceutical environments.
- Strong experience conducting pharmacovigilance audits and knowledge of global regulations (FDA, EMA, ICH).
Benefits:
- Competitive salary range: Assistant Director $121,205 – $162,726 annually; Associate Director $138,908 – $196,548 annually.
- Fully remote work opportunity within the United States.
- Comprehensive benefits package supporting health, financial security, and overall well-being.
Partner Company
This company is a science-driven healthcare organization focused on pharmacovigilance and patient safety. They operate in a collaborative, global environment committed to operational excellence and meaningful healthcare impact.