Full-Time PV Auditor

This role effectively manages and conducts internal and external (third-party) audits to provide independent and objective fact-based opinions and to assure compliance with applicable Primevigilance and/or Client´s procedures and local and global regulatory requirements as well as contractual agreements.

Role and Responsibilities

Principal Responsibilities:

1. Conduct audits initiated by PrimeVigilance, according to the agreed Audit Plan including effective management of pre-audit activities.
2. Audit types include: Audits of PrimeVigilance’s Partners and Vendors/Service Providers Internal Audits of Projects and Processes
3. Document audit findings and recommendations and identify process improvement initiatives and document them in an Audit report in agreed formats and timelines;

Principal Functions and Responsibilities may include but not inclusive of the following:

• Co-Auditor for full Vendor and Internal System Audits
• Lead for Full PV Vendor Audits

Qualifications:

• B.Sc. in Science, Nursing, or related scientific field.
• Sufficient experience in pharmaceutical and/or biotech pharmacovigilance, with a good understanding of GVP-related Quality Management and Assurance, and adequate GxP auditing experience in an Audit Lead role.
• GxP Knowledge: In-depth knowledge of the applicable GxP regulations (eg EU and FDA regulations particularly EU GVP)
• Analytical, written and oral communication skills.
• Must be able to manage all tasks assigned and effectively deliver all expected deliverables in an organized and a timely manner and proactively communicate changes in pre-established goals and deadlines.
• Ability to think strategically and to work collaboratively using risk-based, proactive approaches to problem-solving
• Strong team player
• Good / Strong English language skills (written and spoken) additional languages a plus, but not required
• Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
• Other EDMS e.g. Veeva Vault, Master Control, Trackwise a plus, but not required

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