Senior Area Safety officer

<span id="requisitionDescriptionInterface.reqTitleLinkAction.row1" title="">Senior Area Safety officer</span><span id="requisitionDescriptionInterface.ID1326.row1" title="">-</span><span id="requisitionDescriptionInterface.reqContestNumberValue.row1" title="">2507033263W</span><p></p><h2 xmlns:ftl="http://www.taleo.net/ftl" xmlns:htm="http://www.w3.org/1999/xhtml" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"><span>Description</span></h2><span><span> </span></span><span id="requisitionDescriptionInterface.ID1388.row1" title=""><p><span>Kenvue is currently recruiting for: </span></p> <p><b><span>Senior Area Safety Officer</span></b></p> <p><span>This position report</span> <span>Area Safety Head and is based in Madrid, Spain </span></p> <p><b><span>Who we are</span></b></p> <p><span><span>At </span></span><span><a href="http://kenvue.com/careers"><span>Kenvue</span></a></span><span><span>, 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 </span></span><span>Neutrogena, Aveeno, Tylenol, Listerine, Johnson’s</span><span><span> and BAND-AID® </span></span><span><span>Brand Adhesive Bandages </span></span><span><span>that you already know and love. Science is our passion; care is our talent. Our global team is made up of </span></span><span><span>~ </span></span><span><span>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. For more information, </span></span><span><a href="https://www.youtube.com/watch?v=XhsbOsBiX_M"><span>click here</span></a></span><span><span>.</span></span></p> <p><b><span> </span></b></p> <p><b><span>What you will do</span></b><span><span>  </span></span></p> <p><span>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 a 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. </span></p> <p><span>They will ensure that appropriate product vigilance and risk management systems are set in place to assure appropriate oversight of products within its responsibility. </span></p> <p><u><span>Key Responsibilities</span></u><b><span> </span></b><span></span></p> <p><span><strong>Oversight of the PV System &amp; Overall responsibilities</strong></span></p> <ul> <li><span>Provide oversight of vendor resources within Spain, Andorra, Italy, San Marino, Vatican City, Portugal, Greece and Cyprus. </span></li> <li><span>Support the Area Safety Head in providing relevant local information for the European Economic Area/UK Pharmacovigilance System Master Files. </span></li> <li><span>Perform other agreed tasks assigned by manager. </span></li> <li><span>Record self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective Corrective and Preventative Actions (CAPAs).</span></li> </ul> <p><span><strong>Safety Management &amp; Reporting</strong></span></p> <ul> <li><span>Receive and support the Area Safety Head in the responses to safety-related health authority queries.</span></li> <li><span>Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders). </span></li> <li><span>Maintain oversight of proper identification of local literature articles for Adverse Event (AE) reporting as required.<span>  </span></span></li> <li><span>Perform document management and archiving as required.</span></li> <li><span>Ensure proper documented training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general. </span></li> <li><span>Perform regulatory monitoring for impact on vigilance activities and responsibilities. </span></li> <li><span>Collaborate with the global and local teams to notify local health authorities of any safety issues including SSI/ESI and Signals. </span></li> <li><span>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. </span></li> <li><span>Maintain up-to-date knowledge of local requirements for pharmacovigilance, cosmetovigilance,