Pharmacovigilance Auditor, Manager

reputed company is currently reputed company for a: Pharmacovigilance Auditor, Manager reputed company do At reputed company, we realize the extraordinary power of everyday care. reputed company 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 reputed company people with a workplace culture where every voice reputed company, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and reputed company, 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 reputed company 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, Philippines, Metro Manila, Taguig Work Location: Fully Remote What you will do 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 reputed company Consumer Health Companies (and reputed company 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, reputed company/sensitive system/service provider audits as defined by the scope. Manages reputed company 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 reputed company) 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 reputed company to supervise junior auditors/contractors Deputizes for Audit Manager/ Team reputed company, 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 reputed company issues, reputed company 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 reputed company collaboration with their direct manager. 15% - Department projects: Supports training development, training deployment and maintenance of BRQC PV training curriculum. Supports PV Inspections reputed company required. Develops and maintains audit tools and templates for BRQC Audit Operations reputed company 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 reputed company Proven track record of driving business results through end-to-end collaborative deliverables Strong leadership and stakeholder management. Expertise in PV/GxP expertise, in reputed company 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 reputed company is proud to be an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identify, age, national reputed company, or protected veteran status and will not be discriminated against on the reputed company of disability. If you are an individual with a disability, please reputed company our Disability Assistance page for information on how to request an accommodation. Apply To This Job