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Senior Auditor for Good Clinical Practices and Pharmacovigilance
hace 1 mes
The Senior Auditor for Good Clinical Practices and Pharmacovigilance will lead, support, and report independent GCP/PV audits to assess compliance with applicable regulations, standards, and guidance documents. This role will review and approve corrective action plans in support of the audit observations, ensuring alignment with the company's strategic direction and driving implementation of applicable actions.
Key Responsibilities- Develop and implement a risk-based audit strategy and program, collecting and incorporating input from various stakeholders.
- Lead and conduct global quality regulatory compliance audits and assessments of GCP/GPvP, performing activities with a high degree of independence.
- Provide technical guidance, leadership, mentoring, and training to other auditors on audit-related activities.
- Prepare and review audit reports, ensuring timely completion and accuracy.
- Escalate critical findings to responsible management and support immediate follow-up measures.
- Assess the adequacy of responses to audit findings and identify quality and regulatory compliance issues.
- Lead compliance investigations and initiatives focused on inspection readiness and quality improvement.
- Support Mock Pre-Approval Inspections and Health Authority inspections as needed.
- Review and advise on relevant global policies and procedures.
- Maintain current knowledge of regulations, standards, and guidance documents.
- Strong understanding of GCP/PV regulations and standards.
- Excellent communication and leadership skills.
- Ability to work independently and as part of a team.
- Strong analytical and problem-solving skills.
- Ability to prioritize tasks and manage multiple projects.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. We offer a competitive salary, comprehensive benefits, and opportunities for professional growth and development.
