Global Good Clinical Practices, Pharmacovigilance Auditor

This is a fully remote position, open to applicants in Spain.

📋 Description

• Strategically plan, lead, execute, document, report, and follow up on GCP/PV audits in alignment with Novartis procedures, relevant regulations, quality agreements, standards, and guidance documents.

• Conduct low-risk GCP/PV audits, including investigator site assessments, single-service vendor evaluations, systems/process reviews, and patient-oriented program audits.

• Assist with more complex audits involving country organizations, multi-service vendors, and high-risk vendor evaluations.

• Offer technical guidance and training related to audit activities to ensure consistent audit execution and adherence to quality standards.

• Elevate critical audit findings to the appropriate management and assist with immediate follow-up actions according to Novartis escalation procedures.

• Ensure proper definition, documentation, and follow-up of mitigation plans as necessary.

• Evaluate the adequacy of responses and CAPA plans to audit findings in collaboration with CAPA Approvers and CAPA Coordinators.

• Keep abreast of current regulations, standards, guidelines, and industry expectations.

⛳️ Requirements

• Bachelor’s degree in natural or biological sciences, or a comparable combination of education and relevant experience.

• Approximately 5 years of experience in GCP, GPvP, clinical research, the pharmaceutical industry, health authority, or a similar environment.

• Preferred experience of 1–2 years in GCP auditing.

• Strong understanding of applicable GCP, GPvP, and GxP regulations, guidelines, policies, and procedures.

• Capability to objectively assess compliance issues, manage multiple priorities, and maintain oversight across concurrent activities.

• Solid decision-making and problem-solving abilities, with the capacity to work with a moderate degree of independence.

• Strong quality and compliance orientation, complemented by effective leadership, facilitation, and stakeholder engagement skills.

• Proficiency in English, both written and spoken; additional languages are a plus.

🏝️ Benefits

• Insurance plans

• Retirement plans

• Wellbeing resources

• Global recognition programs

• Flexible and hybrid working options

• Minimum of 14 weeks paid parental leave