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Sr Director Quality Assurance - Pharmacovigilance
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$200,000 - $280,000 a year
Full-time
- Reporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and Medical/Clinical Departments.
- The incumbent will provide support and promote collaboration internally and externally to ensure all systems, processes and their outcomes comply with applicable international and national standards, regulations, and guidelines in partnership with Drug Safety and Pharmacovigilance (DSPV) representative.
- Facilitate and maintain a risk-based and scientific-based quality system to support Good Pharmacovigilance Practice (GVP).
- Establish and maintain Pharmacovigilance inspection readiness in collaboration with DSPV subject matter expert (SME) and act as company's representative during regulatory agency inspections and vendor audits.
- Minimum BS degree in Chemistry or related life sciences discipline required with minimum 10-15 years of experience, 7 years of which are in Pharmacovigilance.
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