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Novartis

Novartis is a leading global pharmaceutical and healthcare research and solutions company dedicated to improving patient lives by uncovering solutions to curren

Global Good Clinical Practices, Pharmacovigilance Auditor

Location

Spain

Posted

2 days ago

Salary

€45.1K - €83.7K / year

Seniority

Senior

Bachelor Degree5 yrs expEnglishGoogle Cloud Platform

Job Description

Global Good Clinical Practices, Pharmacovigilance Auditor

Novartis

• 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
  • minimum of 14 weeks paid parental leave

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