Global Good Clinical Practices, Pharmacovigilance Auditor

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Novartis

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1996

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

Novartis is an innovative medicines company dedicated to reimagining medicine to improve and extend people’s lives. With a presence in over 250 million patients worldwide, Novartis focuses on harnessing scientific breakthroughs to develop transformative, high-value treatments in areas such as cardiovascular, renal and metabolic diseases, immunology, neuroscience, and oncology. The company is committed to diversity, equity, and inclusion, and aims to create a positive impact through societal contributions and environmental sustainability efforts. Furthermore, Novartis engages in research collaborations and embraces modern technology platforms to advance their research and development capabilities, making them a leader in the global healthcare industry.

📋 Description

• Plan, lead, conduct, document, report and follow up on GCP/PV audits in accordance with Novartis procedures, applicable regulations, quality agreements, standards and guidance documents • Perform low-risk GCP/PV audits, such as investigator site audits, single-service vendor audits, systems/process audits and patient-oriented program audits • Support more complex audits, including country organizations, multiservice vendors and higher-risk vendor audits • Provide technical guidance and training on audit-related activities to support consistent audit execution and quality standards • Escalate critical audit findings to responsible management and support immediate follow-up actions in line with Novartis escalation procedures • Ensure appropriate definition, documentation and follow-up of mitigation plans where required • Assess the adequacy of responses and CAPA plans to audit findings in collaboration with CAPA Approvers and CAPA Coordinators • Maintain up-to-date knowledge of applicable regulations, standards, guidelines and industry expectations

🎯 Requirements

• Degree in natural or biological sciences, or equivalent combination of education and relevant experience • Approximately 5 years of experience in GCP, GPvP, clinical research, pharmaceutical industry, health authority or equivalent environment • 1–2 years of GCP auditing experience preferred • Strong knowledge of applicable GCP, GPvP and GxP regulations, guidelines, policies and procedures • Ability to evaluate compliance issues objectively, manage multiple priorities and maintain oversight across parallel activities • Sound decision-making and problem-solving skills, with the ability to work with a moderate level of independence • Strong quality and compliance mindset, with good leadership, facilitation and stakeholder engagement skills • Fluent English, written and spoken; additional languages are an advantage.

🏖️ Benefits

• insurance plans • retirement plans • wellbeing resources • global recognition programs • flexible and hybrid working options • minimum of 14 weeks paid parental leave