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Global Auditor – Clinical Practice Or Pharmacovigilance Auditor

5+ years
Not Disclosed
10 Nov. 26, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Global GCP/PV Auditor
Location: Flexible within Spain (e.g., Barcelona, Madrid, or preferred city)
Division: Operations | Business Unit: Innovative Medicines

Join Novartis as a Global GCP/PV Auditor, contributing to maintaining and enhancing our commitment to exceptional compliance standards. This entry-level global auditing role focuses on Good Clinical Practice (GCP) and Good Pharmacovigilance (GPvP), ensuring adherence to regulations, quality systems, and standards.


Key Responsibilities

  • Audit Execution & Oversight:
    • Plan, lead, document, and report GCP/PV audits in line with Novartis procedures and applicable regulations.
    • Conduct audits on low-risk GCP/PV activities, such as investigator site audits, single-service vendors, and systems/processes.
    • Assist with complex audits, including multi-service vendors, high-risk vendors, and country organizations.
  • Compliance Management:
    • Ensure timely escalation of critical findings and support immediate mitigation measures.
    • Evaluate and document corrective and preventive actions (CAPA) in collaboration with designated follow-up personnel.
  • Knowledge & Training:
    • Maintain up-to-date expertise on GCP, GPvP, and GxP regulations and standards.
    • Provide technical guidance and training to business partners on audit activities.
  • Stakeholder Interaction:
    • Support audits to prepare for and manage Health Authority inspections.

Minimum Requirements

  • Education: Degree in natural/biological sciences or equivalent experience.
  • Experience:
    • 5+ years of GCP/GPvP/clinical or industry-related experience.
    • 1-2 years of auditing experience preferred.
    • Familiarity with GCP, GPvP, and GxP regulations and procedures.
  • Skills:
    • Proficient in English (operational and functional level).
    • Ability to manage multiple tasks, evaluate compliance issues, and maintain independence in decision-making.
  • Travel: Up to 60% travel is required.

Desirable:

  • Experience with Health Authority inspections is a plus.

Why Novartis?

Novartis is driven by the purpose of reimagining medicine to improve and extend lives. Join a global community of passionate professionals making breakthroughs that transform patient outcomes.

Benefits and Rewards: Explore competitive benefits, flexible working arrangements, and professional growth opportunities in the Novartis Life Handbook.

Commitment to Diversity and Inclusion: Novartis fosters an inclusive work environment, valuing diverse teams that reflect the communities and patients we serve.

Employment Type: Full-Time, Regular
Functional Area: Quality | Shift Work: No

Learn More & Apply: Visit the Novartis Talent Network for more opportunities and updates.