Pharmacovigilance Auditor, Manager

Pharmacovigilance Auditor, Manager

Wat we doen

Bij Kenvue realiseren we de buitengewone kracht van dagelijkse verzorging. Gebouwd op meer dan een eeuw erfgoed en geworteld in de wetenschap, zijn we het huis van iconische merken - waaronder NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® en BAND-AID® die je al kent en waar je van houdt. Wetenschap is onze passie; Zorg is ons talent.

Wie we zijn

Ons wereldwijde team bestaat uit ~ 22.000 briljante mensen met een werkcultuur waar elke stem telt en elke bijdrage wordt gewaardeerd. We zijn gepassioneerd door inzichten, innovatie en toegewijd aan het leveren van de beste producten aan onze klanten. Met expertise en empathie betekent een Kenvuer zijn dat je elke dag de kracht hebt om miljoenen mensen te beïnvloeden. We stellen mensen op de eerste plaats, geven er veel om, verdienen vertrouwen met de wetenschap en lossen op met moed - en hebben schitterende kansen voor je klaarliggen! Geef samen met ons vorm aan onze toekomst - en die van jou. Klik voor meer informatie op here.

Rol rapporteert aan:

Associate Director BRQC PV Operations

Locatie:

Asia Pacific, Philippines, Metro Manila, Taguig

Werklocatie:

Volledig op afstand

Wat je gaat doen

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.

Als u een persoon met een handicap bent, kijk dan op onze pagina Hulp bij handicap voor informatie over het aanvragen van een accommodatie.