Full-Time PV Auditor

This role manages and conducts internal and external audits to provide independent, objective opinions and ensure compliance with Primevigilance/Client procedures, local/global regulations, and contracts.

Role and Responsibilities

Principal Responsibilities:

• Conduct audits (PrimeVigilance-initiated, following Audit Plan) and effectively manage pre-audit activities (communication with auditee, plan, checklist).
• Document audit findings, recommendations, and process improvements in Audit reports (agreed formats/timelines).
• Plan, create, and maintain Corrective and Preventative Action Plans (if needed).
• Lead audit teams, ensuring compliance with procedures and regulations.

Principal Functions and Responsibilities (may include, but not limited to):

• Co-Auditor for vendor/internal system audits
• Lead Auditor for PrimeVigilance vendor audits

1) Audit - internal

• Effective pre-audit activities (communication, plan, checklist).
• Conduct audits per Audit Plan.
• Document findings, recommendations, and process improvements in Audit reports.
• Plan, create, and maintain corrective/preventative action plans.
• Lead audit teams.

2) Other Supportive Responsibilities

• Participate in and create/deliver training on regulatory requirements.

Qualifications

• B.Sc. in Science, Nursing, or related scientific field.
• Pharmaceutical/biotech pharmacovigilance experience
• Understanding of GVP-related Quality Management and Assurance
• GxP auditing experience (Audit Lead role)
• GxP Knowledge: In-depth knowledge of applicable GxP regulations (EU, FDA, particularly EU GVP).
• Strong analytical, written, and oral communication skills.
• Ability to manage tasks, meet deadlines, and proactively communicate changes.
• Strategic thinking and collaborative problem-solving skills
• Strong team player
• Good/Strong English language skills (written/spoken); additional languages a plus
• MS Office proficiency (Word, Excel, PowerPoint)
• EDMS proficiency (e.g., Veeva Vault, Master Control, Trackwise) - a plus.

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