Senior Pharmacovigilance Auditor

2 weeks ago


Princeton, New Jersey, United States Pharmalearner Full time

Position Overview: The Senior Pharmacovigilance Auditor will spearhead and execute audits concentrating on Pharmacovigilance functions. This role is pivotal in fostering the ongoing enhancement of the Pharmalearner Quality System, managing inspections, and overseeing regulatory intelligence initiatives.

Key Responsibilities:

  • Pharmacovigilance Audits: Develop and uphold a global pharmacovigilance risk-based strategy for audit and risk assessment.
  • Lead, strategize, and conduct both internal and external GxP audits aligned with the global audit framework and Pharmalearner's operational model.
  • Monitor the formulation, execution, and fulfillment of corrective and preventive actions with both internal and external stakeholders.
  • Maintain a comprehensive tracking system for audits, findings, and corrective measures.
  • Provide business support as the Global Quality representative for routine software and infrastructure lifecycle activities.
  • Drive continuous improvement of the Quality System by generating global metrics and extracting lessons learned from audits and inspections.

Inspections:

  • Assist in the preparation for GxP inspections.
  • Support responses to Regulatory Authorities and contribute to corrective and preventive action plans.
  • Oversee the tracking of inspections, findings, and corrective actions.
  • Stay informed on relevant regulatory requirements and advancements in the regulatory landscape to guide timely updates to Pharmalearner's procedures.

Qualifications:

  • Degree in a natural science or equivalent experience.
  • Proven experience in Pharmacovigilance auditing, with auditor qualification preferred.
  • Several years of experience in clinical, industry, or regulatory authority roles, ideally including Quality Management for Pharmacovigilance or Clinical Development.
  • Expertise in relevant regulations and guidance documents in areas such as Pharmacovigilance and Clinical Development.
  • Familiarity with Monitoring, Quality Assurance, and Good Clinical Practices.

Competencies:

  • Comprehensive understanding of pharmacovigilance requirements.
  • Proficient in audits and CAPA management.
  • Strong grasp of change management processes.
  • Advanced skills in MS Office, particularly Excel and PowerPoint.
  • Exceptional communication skills in English, both written and verbal.
  • Strong analytical and problem-solving abilities.

General Comments: This position is essential for maintaining compliance and enhancing the Quality System within a dynamic regulatory environment.



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