Pharmacovigilance Auditor

3 weeks ago

High Wycombe, Buckinghamshire, United Kingdom Fashion Jobs Full time
Job Title: Pharmacovigilance Auditor - Lead Specialist

We are seeking a highly skilled Pharmacovigilance Auditor - Lead Specialist to join our team at Kenvue. As a key member of our BioResearch Quality & Compliance (Q&C) team, you will be responsible for leading the planning, conduct, and reporting of routine and non-routine Good Pharmacovigilance Practice (GVP) audits.

Key Responsibilities:
  1. Lead the planning, conduct, and reporting of BRQC routine and non-routine audits of activities, data, internal facilities, and processes in GVP to verify adherence to corporate policies, internal standards/requirements, and compliance with applicable regulatory requirements.
  2. Conduct non-routine audits, including Due Diligence, for cause audits, cross-functional, system/service provider audits as defined by the scope.
  3. Support other auditors in planning, conduct, and reporting of audits.
  4. Ensure the relevant standard procedures, diagnostic tools, and audit plans and scope are fully understood and applied in audit activities.
  5. Participate in regulatory inspections in core and supporting roles.
  6. Contribute to the overall PV Quality & Compliance strategy.
  7. Assist in preparation and delivery of training materials.
  8. Advise and contribute to coaching, including audit outcomes and Corrective and Preventive actions.
  9. Complete training requirements in a timely manner to ensure inspection readiness at all times.
  10. Take an active role in projects as assigned by supervisor and interact with key stakeholders as appropriate.
  11. Meet priorities, checkpoints, and timelines for all aspects of work and projects to achieve adequate progress.
  12. Provide expertise and knowledge to others in BRQC, Business Partners, and the core business sector on quality and compliance processes/procedures.
  13. Interpret and apply regulations/policies to issues of moderate complexity, when required.
Requirements:
  1. A minimum of a Bachelor's Degree is required.
  2. A minimum of 5 years of experience in pharmacovigilance, quality, and/or compliance is required.
  3. Comprehensive knowledge of the drug development process, applicable regulations (GxP), R&D practices, and scientific and quality terminology is required.
  4. Knowledge of procedural and records management requirements in a regulated industry preferred.
  5. Prior pharmaceutical, consumer personal products, and quality/compliance-related experience preferred.
  6. Must have excellent communication skills and be fluent in written and spoken English.
  7. Must be proficient in Microsoft Office applications and possess a Quality mindset.
What We Offer:
  1. Competitive Benefit Package.
  2. Paid Company Holidays, Paid Vacation, Volunteer Time & More.
  3. Learning & Development Opportunities.

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