Assistant/Associate Director, Pharmacovigilance Quality Assurance
New
J
JobgetherPharmaceutical, Biotechnology
Based in United StatesFull-TimeManager
Salary121,205 - 196,548 USD per year
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Job Details
- Experience
- 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.
- Required Skills
- Quality Assurance
Requirements
- Bachelor’s degree with 8+ years (Assistant Director) or 12+ years (Associate Director) of relevant experience.
- Master’s degree with 6+ years (Assistant Director) or 8+ years (Associate Director) of relevant experience.
- PhD with 3+ years (Assistant Director) or 5+ years (Associate Director) of relevant experience.
- Extensive experience in GVP quality assurance, clinical trial safety, or pharmacovigilance environments.
- Demonstrated experience conducting internal, business partner, and service provider pharmacovigilance audits.
- Strong knowledge of global pharmacovigilance regulations, FDA, EMA, ICH guidelines, and GCP regulations.
- Experience supporting regulatory inspections and external quality assessments.
- Proficiency in managing SOPs, CAPAs, deviations, change controls, and quality agreements.
- Understanding of clinical development and risk-based quality management.
- Ability to travel as needed for the role.
- Excellent organizational, communication, and problem-solving skills.
Responsibilities
- Implement and maintain a comprehensive GVP-compliant quality assurance program for clinical trial and post-market processes.
- Plan, conduct, and report pharmacovigilance audits, including follow-up on corrective and preventive actions (CAPA).
- Develop and manage audit plans, SOPs, guidance documents, and templates.
- Support regulatory inspection readiness and participate in health authority inspections and external assessments.
- Provide quality guidance and training to stakeholders in clinical development and patient safety.
- Monitor regulatory intelligence and implement changes for evolving safety requirements.
- Provide QA support for investigations, deviations, change controls, and risk assessments.
- Oversee pharmacovigilance service providers through qualification and risk-based monitoring.
- Maintain quality metrics and dashboards for management oversight and trend analysis.
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