<p style="text-align:left"><b>Job Description</b></p><p><b>General Summary:</b></p><p></p><p>The International Pharmacovigilance (PV) Senior Specialist is responsible for supporting management of the GPS International PV structure. The International PV Specialist works with a degree of independence and supports troubleshooting problems and improving internal procedures, to ensure compliance with applicable regulatory requirements.</p><p></p><p><b>Key Duties and Responsibilities:</b></p><ul><li>Assists with ensuring that all GPS procedures are compliant with global PV regulations</li><li>Supports the oversight of local Responsible Persons for Pharmacovigilance (RPPVs) and key vendors</li><li>Researches PV regulations and guidelines</li><li>Reviews, assesses, and tracks global PV regulatory intelligence</li><li>Reviews PV agreements which support local and regional PV requirements</li><li>Works cross-functionally to plan and verify safety database configuration compliance based on PV intelligence and geographic expansion activities</li><li>Supports cross-functional geographic expansion initiatives</li><li>Reviews and may be responsible for authoring Standard Operating Procedures (SOPs) and Work Instructions (WIs) with support from line management</li><li>Conducts presentations of safety issues, initiatives and projects</li><li>Represents GPS and Vertex regarding patient safety related matters as assigned</li><li>Ensures prompt and accurate response to cross-functional teams and vendor questions on a continuous basis</li><li>Collaborates and continuously builds and fosters relationships cross-functionally and on a global scale with individuals of all levels</li><li>Be knowledgeable about and provide Pharmacovigilance information and guidance to cross-functional teams</li><li>Helps to identify key departmental needs and provides constructive input on solutions</li></ul><p>May also:</p><ul><li>Collect, analyze and utilize data and feedback / share information to identify opportunities to improve relationships cross-functionally, working effectively and lead business-wide improvements</li><li>Liaise between GPS and members of International teams<ul><li>Communicate and coordinate activities and bridge alignment</li><li>Triage and escalate patient safety related matters as appropriate</li></ul></li><li>Proactively raise awareness and promote GPS activities, policies and best practices</li><li>Share information for innovative corporate improvement projects as endorsed</li></ul><p></p><p><b>Knowledge and Skills:</b></p><ul><li>Effectively operates in a matrix environment to support cross-functional initiatives</li><li>Ability to multi-task with sound attention to detail</li><li>Solid written and verbal communication skills</li><li>Strong sense of responsibility and an ability to work autonomously, as well as acting as a strong team player</li><li>Understands established procedures and communicates those procedures to others</li><li>Ability to adapt and react to change in priorities and effectively manage workload with support from line management</li><li>Maintains a current understanding of global PV regulatory requirements</li><li>Ability to apply knowledge to new situations</li><li>Proficiency in using Microsoft Office applications required (Word, Excel, and PowerPoint)</li></ul><p></p><p><b>Education and Experience:</b></p><ul><li>Health care professional with a university degree (i.e., third level qualification) in life sciences or allied health fields required; <span>significant years</span> of direct pharmacovigilance experience;</li><li>Strong knowledge of Brazil <span>& LATAM</span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;"> pharmacovigilance</span> regulations, standards, and best practices regarding safety processing and reporting, safety surveillance, and pharmaceutical industry compliance activities in the post-marketing approval setting;</li><li>Excellent oral and written communication skills in English (required), <span>Spanish (preferred)</span>, and Brazilian Portuguese (required).</li></ul><p></p><p><b>Flex Designation:</b></p>Remote-Eligible<p style="text-align:inherit"></p><p style="text-align:left"><b>Flex Eligibility Status:</b></p><p>In this Remote-Eligible role, you can choose to be designated as: <br>1.    <b>Remote</b>: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; <b>or select</b> <br>2.    <b>Hybrid</b>: work remotely up to two days per week; <b>or select</b><br>3.    <b>On-Site</b>: work five days per week on-site with ad hoc flexibility.</p><p>Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. </p><p></p><p>#LI-Remote</p><p style="text-align:left"><b>Company Information</b></p><p style="text-align:left"><span>Vertex is a global biotechnology company that invests in scientific innovation. </span></p><p style="text-align:inherit"></p><p style="text-align:left"><span>Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. </span></p><p style="text-align:inherit"></p><p style="text-align:left"><span>Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at <span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span class="WEH1"><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">ApplicationAssistance@vrtx.com</span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></p>