Global Good Clinical Practices, Pharmacovigilance Auditor

Novartis

Global GCP/PV Auditor ensuring compliance in clinical and pharmacovigilance activities across global operations. Leading audits, assessing risks, and providing quality guidance to business partners.

Posted 6/26/2026full-timeRemote • 🇪🇸 SpainMid-LevelSenior💰 €45,100 - €83,700 per yearWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GCP auditingGPvPGxP regulationsclinical researchCAPA plansaudit documentationrisk assessmentquality standardsinvestigator site auditsvendor audits

Soft Skills

decision-makingproblem-solvingleadershipfacilitationstakeholder engagementobjective evaluationmulti-priority managementindependencecommunicationquality mindset

Industry Keywords

pharmaceutical industryhealth authorityaudit executionregulatory compliancequality agreementsguidance documentsaudit findingsmitigation planstraining on audit activitiesescalation procedures

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

insurance plans
retirement plans
wellbeing resources
global recognition programs
flexible and hybrid working options
minimum of 14 weeks paid parental leave