PV Auditor - Remote

Overview

The PV Auditor role involves managing and conducting internal and external audits to ensure compliance with regulatory requirements and internal procedures, contributing to the quality assurance processes in pharmacovigilance.

In Short

• Conduct internal and external audits of processes and partners.
• Document findings and recommendations in audit reports.
• Manage pre-audit activities and audit plans.
• Lead audit teams and ensure compliance with regulations.
• Participate in workshops and training sessions.
• Identify process improvement initiatives.
• Maintain Corrective and Preventative Action Plans.
• Work collaboratively with teams across the organization.
• Communicate effectively with stakeholders.
• Support the development of training materials.

Requirements

• B.Sc. in Science, Nursing, or related field.
• Experience in pharmacovigilance and GxP auditing.
• Strong understanding of GVP regulations.
• Excellent analytical and communication skills.
• Ability to manage tasks and deadlines effectively.
• Proficient in MS Office applications.
• Knowledge of EDMS like Veeva Vault is a plus.
• Strong team player with strategic thinking abilities.
• Good English language skills; additional languages are a plus.

Benefits

• Training and career development opportunities.
• Emphasis on personal and professional growth.
• Supportive working environment.
• Opportunity to work with global colleagues.