Global Good Clinical Practices, Pharmacovigilance Auditor

🕒 June 26

🇪🇸 Spain – Remote

💵 €45.1k - €83.7k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔎 Auditor

👻 Ghost score 37%

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Logo of Novartis

Novartis

10,000+ employees

Founded 1996

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

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 • Perform low-risk GCP/PV audits, including investigator site, single-service vendor, systems/process and patient-oriented program audits • Support complex audits involving country organizations, multiservice vendors and higher-risk vendors • Provide technical guidance and training on audit-related activities • Escalate critical audit findings and support immediate follow-up actions • Define, document and follow up on mitigation plans • Assess audit finding responses and CAPA plans with CAPA Approvers and CAPA Coordinators • Maintain current knowledge of regulations, standards, guidelines and industry expectations • Approve follow-up corrective and preventive activities and contribute to quality assurance training needs

🎯 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 • Travel of up to 50% of the time

🏖️ Benefits

• Relocation support • Insurance plans • Retirement plans • Wellbeing resources • Global recognition programs • Flexible and hybrid working options, where possible • Minimum of 14 weeks paid parental leave • Performance-based bonus eligibility

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