Pharmacovigilance Auditor - Lead Specialist

Description

Kenvue is currently recruiting for a:

BioResearch Q&C Pharmacovigilance Auditor - Lead Specialist

This position is based at our High Wycombe office (hybrid working policy)

This position requires overnight travel, nationally and internationally, up to 50%.

Who We Are

At Kenvue, we realise the extraordinary power of everyday care.

Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® and BAND-AID® that you already know and love.

Science is our passion; care is our talent.

Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers.

With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day.

We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you! Join us in shaping our future-and yours.

What you will do

The Bioresearch Quality & Compliance (Q&C) Pharmacovigilance Auditor - Lead Specialist independently leads the planning, conduct and reporting of routine/non-routine Good Pharmacovigilance Practice (GVP) audits, including internal processes, partners and service providers.

These audits provide an independent quality assessment to verify compliance with appropriate regulations, SOPs, processes, etc.

as they pertain to company-sponsored R&D and post-marketing pharmacovigilance activities, within the regions (Americas, Europe Middle East & Africa (EMEA), Asia Pacific).

Also contributes to or may lead other compliance and quality activities, as assigned.

• Independently leads 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

• Non-routine audits include Due Diligence, for cause audits, cross-functional, system/service provider audits as defined by the scope

• May support other auditors in planning, conduct and reporting of audits

• Ensures the relevant standard procedures, diagnostic tools, and audit plans and scope are fully understood and applied in audit activities

• Participates in regulatory inspections in core and supporting roles

• Contributes to the overall PV Quality & Compliance strategy

• Assists in preparation and delivery of training materials

• Advises and contributes to coaching, including audit outcomes and Corrective and Preventive actions

• Completes training requirements in a timely manner to ensure inspection readiness at all times

• Takes an active role in projects as assigned by supervisor and interacts with key stakeholders as appropriate

• Meets priorities, checkpoints and timelines for all aspects of work and projects to...