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Pv Auditor

Primevigilance
PrimeVigilance
2+ years
Not Disclosed
10 April 24, 2025
Job Description
Job Type: Education: B.Sc 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

Job Title: PV Auditor
Location: Remote
Employment Type: Full-time
Department: PV QA


About the Company:

PrimeVigilance, part of the Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. The company has consistently achieved global organic growth, with teams based in Europe, North America, and Asia, offering services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

PrimeVigilance is dedicated to providing exceptional support to pharmaceutical and biotechnology partners, building long-lasting relationships, and becoming a global leader in its field. The company covers all therapy areas, including medical devices.

PrimeVigilance values its employees by offering excellent training and development opportunities. The company emphasizes employee well-being, mental health, and work-life balance to ensure high-quality client service.


Job Responsibilities:

  • Manage and conduct internal and external (third-party) audits, ensuring compliance with PrimeVigilance's procedures, local/global regulatory requirements, and contractual agreements

  • Perform audits of PrimeVigilance’s partners, vendors/service providers, and internal processes

  • Document audit findings and recommendations, and identify process improvement opportunities, creating Audit reports within agreed formats and timelines

  • Serve as Co-Auditor for full Vendor and Internal System Audits, and Lead for Full PV Vendor Audits


Required Qualifications:

  • B.Sc. in Science, Nursing, or a related scientific field

  • Sufficient experience in pharmaceutical/biotech pharmacovigilance with a solid understanding of GVP-related Quality Management and Assurance

  • Adequate GxP auditing experience, with a proven ability in an Audit Lead role

  • In-depth knowledge of applicable GxP regulations (e.g., EU and FDA regulations, particularly EU GVP)

  • Strong analytical, written, and oral communication skills

  • Ability to manage tasks effectively, deliver expected results in a timely manner, and proactively communicate changes in goals and deadlines

  • Strategic thinking, with the ability to work collaboratively using risk-based, proactive problem-solving approaches

  • Strong team player

  • Proficiency in MS-Office applications (Word, Excel, PowerPoint)

  • Experience with EDMS systems (e.g., Veeva Vault, Master Control, Trackwise) is a plus


What We Offer:

  • Internal training and career development opportunities

  • Strong focus on personal and professional growth

  • A friendly, supportive working environment

  • The opportunity to collaborate with colleagues worldwide, with English as the company language

  • A company culture driven by core values:

    • Quality

    • Integrity & Trust

    • Drive & Passion

    • Agility & Responsiveness

    • Belonging

    • Collaborative Partnerships