Accountabilities:

The Assistant/Associate Director, Pharmacovigilance Quality Assurance will support the execution of a risk-based quality program while providing expert guidance across pharmacovigilance and clinical safety activities. The role requires strong ownership of audit programs, compliance initiatives, and quality improvements while partnering with internal teams and external service providers.

• 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.
• Review audit findings and responses, ensuring CAPA plans address root causes and include appropriate effectiveness checks.
• Develop and maintain audit plans, standard operating procedures, guidance documents, templates, and other quality documentation.
• Support regulatory inspection readiness activities and participate in health authority inspections, partner audits, and external assessments.
• Provide quality guidance and training to stakeholders involved in clinical development, patient safety, and safety-related processes.
• Monitor regulatory intelligence and support implementation of evolving pharmacovigilance and clinical safety requirements.
• Provide QA support for deviations, investigations, change controls, CAPAs, quality events, and risk assessments.
• Support oversight of pharmacovigilance service providers, including qualification activities, quality agreements, governance, and ongoing risk-based monitoring.
• Maintain quality metrics and dashboards to support management oversight, trend analysis, and proactive risk management.
• Mentor and support internal and external quality personnel while contributing to broader cross-functional quality initiatives.

Requirements:

The ideal candidate will bring extensive pharmacovigilance quality assurance experience, strong regulatory knowledge, and the ability to influence stakeholders across a global healthcare environment. Candidates should combine technical expertise with strong communication, organizational, and problem-solving abilities.

• 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, biotechnology, or service provider environments.
• Strong experience conducting pharmacovigilance audits, including internal process audits, business partner audits, and service provider audits.
• Knowledge of global pharmacovigilance regulations, FDA and EMA requirements, ICH guidelines, GCP regulations, and applicable health authority guidance.
• Experience supporting regulatory inspections, inspection readiness activities, and external quality assessments.
• Understanding of clinical development processes, risk-based quality management approaches, and post-market safety activities.
• Experience creating and managing SOPs, controlled documents, CAPAs, deviations, change controls, and quality agreements.
• Familiarity with pharmacovigilance systems, computer system validation, and data integrity principles is preferred.
• Strong written and verbal communication skills with the ability to collaborate effectively across multiple functions.
• Excellent organizational skills with the ability to manage competing priorities in a fast-paced environment.
• Willingness and ability to travel as needed, including occasional short-notice travel.

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.
  • Opportunities to contribute to innovative healthcare solutions with meaningful patient impact.
  • Collaborative environment focused on scientific excellence, professional growth, and continuous improvement.
  • Opportunities to work with cross-functional global teams and expand expertise in pharmacovigilance quality assurance.