Global Good Clinical Practices / Pharmacovigilance Auditor

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Kerr Dental

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1891

⚕️ Healthcare Insurance

🔬 Science

🧘 Wellness

💰 Debt Financing on 2005-12

Healthcare Insurance • Science • Wellness

Kerr Dental is a company that focuses on providing dental professionals with innovative and high-quality dental products. They offer a wide range of solutions for dental procedures, including restorative materials, dental bonding agents, and hygiene products. With a commitment to advancing dental healthcare, Kerr Dental is dedicated to enhancing patient outcomes and supporting the dental 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 • a minimum of 14 weeks paid parental leave