Senior CSV Expert - GPvP

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia, and the Americas.

Overview

We are looking for a skilled and experienced Senior CSV Expert to join our IT Compliance team. The ideal candidate will have a strong background in IT compliance and validation for pharmaceutical systems, with a focus on pharmacovigilance. As part of a long-term project, the role will involve leading the implementation of Veeva Vault Safety, ensuring compliance and security across manufacturing, laboratory, and industrial systems. The candidate should be able to work independently, with excellent organizational and communication skills, and the ability to escalate issues when necessary.

Responsibilities:

• Oversee all aspects of IT compliance for pharmacovigilance systems, including validation, regulatory adherence, and integration of system security measures.
• Manage the end-to-end implementation of Veeva Vault Safety, ensuring that the system is properly configured, validated, and compliant with industry standards and regulations.
• Work closely with internal IT teams, business units, and external partners to ensure smooth system deployment, effective testing, and continuous support for pharmacovigilance-related IT projects.
• Develop, execute, and maintain comprehensive validation documentation, including risk assessments, validation protocols, test plans, and reports, ensuring that all processes meet internal and external regulatory requirements.
• Ensure that all systems comply with relevant regulatory frameworks, including 21 CFR Part 11, GxP, and other applicable standards within the pharmaceutical industry.
• Proactively identify and resolve compliance and validation issues, providing recommendations for corrective actions. Escalate any significant risks or roadblocks to project management and leadership in a timely manner.
• Provide guidance and training to internal teams regarding IT compliance processes, validation practices, and system-specific requirements for pharmacovigilance.
• Prepare and deliver comprehensive reports on validation progress, compliance status, and system performance. Maintain up-to-date records on all compliance activities and project milestones.
• Actively contribute to the enhancement of IT compliance practices and the implementation of best practices across the organization.

Qualifications:

• Education: Bachelor's or Master's degree in Computer Science, Information Technology, Life Sciences, or a related field. Relevant certifications in IT compliance, validation, or pharmacovigilance are a plus.
• Minimum of 5 years of experience in IT compliance and validation within the pharmaceutical, healthcare, or regulated industry.
• Proven experience with pharmacovigilance systems, especially in a CSV (Computerized System Validation) context.
• Strong expertise in the implementation and validation of Veeva Vault Safety or similar pharmacovigilance systems.
• In-depth understanding of IT security, data protection, and regulatory compliance requirements (e.g., GxP, 21 CFR Part 11, HIPAA, etc.).
• Fluency in English and French.

Next Steps:

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there is a positive match, a technical interview with the Hiring Manager will be arranged. Following a successful interview with the Hiring Manager, the recruiter will contact you for the next steps or to discuss the offer. If the feedback is not positive, we will inform you that the recruitment process has been halted.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.