PV Auditor

Jobtailor; Deutschland; Hybrid; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

Jobtailor in Germany seeks an experienced Pharmacovigilance Auditor to lead audits for pharmaceutical and biotechnology clients and to ensure strict GVP compliance. You will plan, execute, report, and follow up on varied audits, developing CAPA plans to drive continual improvement.

The role supports remote audits and requires up to 40% travel, with a focus on delivering timely, high-quality quality assurance projects in a fast-paced environment.

Qualifikationen

• Experience conducting and leading internal and external Pharmacovigilance audits across diverse stakeholders.
• Expert knowledge of national and international pharmacovigilance legislation and guidelines.
• Proven ability to manage projects with timely deliverables.
• Strong problem-solving and pragmatic decision-making abilities.
• Ability to conduct remote audits and handle up to 40% travel.

Aufgaben

• Plan, prepare, conduct, report, and follow up on various types of Pharmacovigilance audits.
• Develop and follow up on CAPA plans.
• Execute audits based on regulatory requirements and Good Pharmacovigilance Practice (GVP).
• Perform GVP quality assurance projects for pharmaceutical and biotechnology clients.

Ausbildung

Bachelor's Degree in Life Sciences

Jobbeschreibung

• Plan, prepare, conduct, report, and follow up on various types of Pharmacovigilance audits
• Develop and follow up on CAPA plans
• Execute audits based on regulatory requirements and Good Pharmacovigilance Practice (GVP)
• Perform GVP quality assurance projects for pharmaceutical and biotechnology client companies

Requirements

• Experience in conducting and leading internal and external Pharmacovigilance audits for a variety of stakeholders
• Expert knowledge of national and international Pharmacovigilance legislation and guidelines
• Proficient in managing projects and ensuring deliverables are provided timeously
• Ability to identify issues and offer solutions in a pragmatic way
• Bachelor’s Degree in Life Sciences preferred
• Ability to conduct remote audits
• Up to 40% travel

Core Competencies

Demonstrates expertise in conducting Pharmacovigilance audits and managing CAPA plans while ensuring compliance with national and international regulations. Proficient in project management and delivering quality assurance projects for pharmaceutical and biotechnology clients.

Highest-signal resume keywords

• Pharmacovigilance Audits
• Good Pharmacovigilance Practice (GVP)
• CAPA Management
• Project Management
• Pharmacovigilance Legislation

ATS Optimization Keywords

Hard Skills

• Pharmacovigilance Audits
• CAPA Development
• Quality Assurance
• Regulatory Compliance
• Project Management

Soft Skills

• Problem Solving
• Pragmatic Thinking

Industry Keywords

• Pharmaceutical
• Biotechnology
• GVP
• Remote Audits
• Stakeholder Management