Senior Auditor

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Descripción del trabajo

Come work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation.

Job Description - Senior Area Safety Officer (2507033263W)

Who we are

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 Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse and brilliant people, 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 the life of 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.

What you will do

The Senior Area Safety Officer is responsible for ensuring that the local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies / procedures at local, regional, and global levels and in accordance with any product vigilance agreements with third-party business partners. This role will act as the Local Operating Company (LOC)’s and assigned territories main point of contact for pharmacovigilance matters (including cosmetovigilance, materiovigilance, and nutrivigilance) with the local health authority.

They will ensure that appropriate product vigilance and risk management systems are set in place to assure appropriate oversight of products within its responsibility.

Key Responsibilities

• Oversight of the PV System & Overall responsibilities
• Provide oversight of vendor resources within Spain, Andorra, Italy, San Marino, Vatican City, Portugal, Greece, and Cyprus.
• Support the Area Safety Head in providing relevant local information for the European Economic Area / UK Pharmacovigilance System Master Files.
• Perform other agreed tasks assigned by the manager.
• Record self-identified non-conformances and collaborate with the global team to investigate non-conformances while developing and implementing effective Corrective and Preventative Actions (CAPAs).
• Safety Management & Reporting
• Receive and support the Area Safety Head in the responses to safety-related health authority queries.
• Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders).
• Maintain oversight of proper identification of local literature articles for Adverse Event (AE) reporting as required.
• Perform document management and archiving as required.
• Ensure proper documented training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.
• Perform regulatory monitoring for impact on vigilance activities and responsibilities.
• Collaborate with the global and local teams to notify local health authorities of any safety issues including SSI / ESI and Signals.
• Manage reporting / submissions of safety reports / updates / information (e.g., SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other Kenvue departments as applicable.
• Maintain up-to-date knowledge of local requirements for pharmacovigilance, cosmetovigilance, materiovigilance, and nutrivigilance, including reporting requirements (for all applicable product classes in the territory) and collaborate with the global team to implement process changes required for identification of new requirements.
• Ensure pharmacovigilance compliance of local company-sponsored programs and research activities as applicable.
• Perform translation for ICSR and PV-related documents, as required.
• Provide technical and strategic input and participate in projects / workstreams led by the Kenvue Medical Safety teams or LOC.
• Procedural Document
• Develop, update, and implement local procedures to ensure compliance with Kenvue global procedures and national requirements.
• Ensure current knowledge of all relevant company procedures and training.
• Audit & Inspection Readiness
• Support local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA plans as applicable.
• PV Contract Management
• Management of PV clauses to be included within local agreements.
• Business Continuity
• Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage).

What we are looking for

Required Qualifications

• University degree in related field (Pharmacy, Healthcare)
• At minimum 3 years of working experience in the Pharmaceutical industry, within a role with product vigilance responsibility.
• Sound knowledge of general medicine, pharmacy, and clinical practice, or another relevant scientific / medical field.
• Proven ability to organize workflow activities.
• Awareness of and familiarity with industry principles of product vigilance, drug development, and pharmacology.
• Knowledge of global, regional, and local procedural documents as applicable.
• Computer literate with knowledge of relevant IT safety systems.
• Good verbal and written communication skills.
• Ability to establish and maintain open relationships within the organization and with authorities.
• Demonstrable knowledge of all local requirements and of global aspects of product safety.
• Fluency in the English language.
• Knowledge of Portuguese, Italian, or Greek languages would be an advantage.

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.

Primary Location

Europe / Middle East / Africa-Spain-Community of Madrid-Madrid

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