Pharmacovigilance Auditor, Manager

Was wir tun

Bei Kenvue erkennen wir die außergewöhnliche Kraft der täglichen Pflege. Aufbauend auf über einem Jahrhundert Tradition und verwurzelt in der Wissenschaft, sind wir das Haus der ikonischen Marken - darunter NEUTROGENA®, AVEENO®, TYLENOL,® LISTERINE®, JOHNSON'S® und BAND-AID®, die Sie bereits kennen und lieben. Wissenschaft ist unsere Leidenschaft; Fürsorge ist unser Talent.

Wer wir sind

Unser globales Team besteht aus ~ 22.000 brillanten Mitarbeitern mit einer Arbeitsplatzkultur, in der jede Stimme zählt und jeder Beitrag geschätzt wird. Wir sind leidenschaftlich an Erkenntnissen interessiert, Innovation und dem Engagement, unseren Kunden die besten Produkte zu liefern. Mit Fachwissen und Einfühlungsvermögen bedeutet ein Kenvuer zu sein, die Macht zu haben, jeden Tag Millionen von Menschen zu beeinflussen. Wir stellen den Menschen an die erste Stelle, kümmern uns leidenschaftlich, gewinnen Vertrauen in der Wissenschaft und lösen Lösungen mit Mut – und haben brillante Möglichkeiten, die auf Sie warten! Gestalten Sie mit uns unsere Zukunft – und Ihre. Für weitere Informationen, klicken Sie auf hier.

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Was Sie tun werden

The Pharmacovigilance Auditor, Manager will collaborate closely with senior leaders across R&D and Medical Safety to drive quality and compliance.  Additionally, this role is responsible for the implementation of the global compliance audit program to ensure that the development programs, Marketing Authorisation Holders, functions, processes and systems for Kenvue Consumer Health Companies (and all partners) are in compliance with company standards, Good Practices, and Health Authority guidelines and regulations.

This role reports to the Associate Director, PV Audit Operations and will be based in either Taguig, Philippines or Mumbai, India. The schedule is day shift, and the work arrangement is fully remote.

Main responsibilities will include:

Auditing

• Independently leads the planning, conduct, reporting of BRQC routine and non-routine audits/assessments/inspections of activities, data, internal facilities and processes in pharmacovigilance and other GxP (as appropriate) to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope. Manages complex or business critical audits/issues in a supporting or leading role.
• Supports other auditors in planning, conducting and reporting of audits.
• Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.
• Supports the CAPA process following the audit as needed.
• Encourages and supports others to properly manage and document the risk-based approach in the audit planning and Conduct
   

Inspection Support

• May participate in regulatory inspections in a leadership role (e.g. host, backroom lead)
   

Training & Development

• Identifies training needs. Supports Development and provides training. Independently advises and coaches auditors.
• Involved with the review and approval of curriculum as applicable
• Completes training requirements in a timely manner to always ensure inspection readiness
   

People Management

• Able to supervise junior auditors/contractors
• Deputizes for Audit Manager/ Team Lead, as required
   

Project Management

• Leads initiatives and actively participates in key projects across the organization or company. Interacts with key stakeholders and can influence and effectively drive projects to completion
   

Expertise

• Actively shares business area and regulatory knowledge/expertise. May act as a primary contact for internal and/or external stakeholders.
• Conducts Peer review of audit reports, as required
• Independently provides consultation and advice to Business Partners on quality and compliance processes/procedures.
• Interprets and applies regulations/policies to unique and/or complex issues, when requirements

Approximate % of Time Tasks/Duties/Responsibilities

70% - Conduct and report PV / CV risk-based audits and in accordance with the BRQC Annual Audit Schedule and applicable procedures.

15% - Trains, supports, and mentors PV auditors, providing meaningful feedback on a person’s performance in close collaboration with their direct manager.

15% - Department projects:

• Supports training development, training deployment and maintenance of BRQC PV training curriculum.
• Supports PV Inspections when required.
• Develops and maintains audit tools and templates for BRQC Audit Operations

What We Are Looking For

Required Qualifications:

• 10 years of experience in Pharmacovigilance
• 3-5 years of experience in Pharmacovigilance Auditing
• Bachelor's degree or equivalent in a relevant field, such as Pharmacy, Sciences, Medical or Bio related
• Proven track record of driving business results through end-to-end collaborative deliverables
• Strong leadership and stakeholder management.
• Expertise in PV/GxP expertise, in complex global environments
• Strong analytical, problem-solving skills and introduction of Ai capabilities
• Ability to work collaboratively in a matrixed organization across different backgrounds.

What’s in it for you

• Competitive Benefit Package
• Health and Wellness reimbursements, Volunteer Days, and much more!
• Learning & Development Opportunities
• Flexible Work Arrangement,
• Employee Resource Groups 

Kenvue is proud to be an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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