Pharmacovigilance Audit Manager

What we do

At 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.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.  We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact 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. For more information, click here.

Role reports to:

Location:

Work Location:

What you will do

Kenvue is currently recruiting for

Pharmacovigilance Audit Manager

Job location : India

Job type: Fully remote

Assures compliance with regulatory requirements and internal procedures by planning, conducting and reporting audits of pharmacovigilance (PV) activities supporting local operating company and third parties. Focuses on quality, compliance and PV technical issues as a primary source of interpretation in the compliance area. Audits the initiation and execution of activities aimed at evaluating and maintaining quality. Audits developed quality/PV agreements, implemented compliance programs, performed annual product/promotional reviews, trackers and reports, quality/PV metrics, ensures continuous improvement, and performs quality assessments of local operating companies and third parties. Ensures good documentation practices for compliance to regulatory requirements, contracts, enterprise and company standards. Makes decisions on nonconformance, identifies and ensures corrective actions and preventative actions are resolve compliance risks, and helps local operating cmpanes prepare for inspections.

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 Percentage 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:

• 15 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.

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.