Work as Pharmacovigilance Auditor at Kenvue

Kenvue, we realize 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 up with 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.

Post : Pharmacovigilance Auditor, Manager

Job Description
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.

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

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

Additional Information
Experience : 3-5 years
Qualification : Bachelor's degree or equivalent in a relevant field, such as Pharmacy, Sciences, Medical or Bio related
Location : Maharashtra, Greater Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Pharmacovigilance
End Date : 31st July 2026