Pharmacovigilance Audit Manager

Kenvue is currently recruiting for a: 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: Associate Director BRQC PV Operations Location: Asia Pacific, India, Karnataka, Bangalore Work Location: Fully Remote 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.