Global Good Clinical Practices / Pharmacovigilance Auditor
Location
Spain
Posted
2 days ago
Salary
€45.1K - €83.7K / year
Seniority
Senior
Job Description
Global Good Clinical Practices / Pharmacovigilance Auditor
Kerr Dental
• 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.
Job 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
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