Senior Good Clinical Practices/PV Auditor

Jan 23, 2022

Job Description

Support Mock Pre-Approval Inspections (PAIs) and Health Authority (HA) inspections as needed.
Proactively research local and global initiatives, trends and events that impact maintenance of compliance. Mentor junior GCP/PV staff as required.Complete any other requests from Global GxP Audit.
What you’ll bring to the role:
Execution of the risk based Unified Quality Audit Plan (UQAP).
Assigned audits led appropriately, delivered on time and according to Global GxP Audit quality standards.
Accuracy of findings and completion of audits and finalization of audit reports within established timelines, procedures and agreed upon standards/Key Performance Indicators (critical metrics). Effective analysis of audit metrics and causes of non-compliance.
Timely escalation through proper channels of issues and findings that impact NVS Good Clinical Practice/Pharmacovigilance and risk benefit evaluation capabilities.
Effective collaboration on quality/compliance remediation and improvement initia- tives; timely completion of projects.
Timely review and feedback on policies, procedures and associated documents.
You’ll receive:
A total compensation package that includes a competitive salary, performance bonus, learning platforms, pension plan, major medical expenses, flexible working environment, global employee recognition scheme, flexible benefits, parental leave, collaborative and empowered culture, development opportunities and so much more.

Why Novartis? 769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!

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Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

English fluency at operational and functional level (as first or second language; second language a plus)

• 7+ years of GCP/PV/Pharmaceutical
Industry/Health Authority experience or equivalent;
• 3 years of GCP/PV auditing experience; 5 years preferred; experienced in both GCP and PV auditing is ideal;
• Willingness to travel approximately 60% of the time.
• Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision;
• Ability to address a variety of tasks within the same timeframe while maintaining oversight; ability to maintain a high degree of independence with respect to decision making and problem solving;
• Experience with Health Authority inspections and interaction;
• Excellent quality and compliance leadership and facilitation skills
Novartis Technical Operations
Distrito Federal
Full Time
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Senior Good Clinical Practices/PV Auditor

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