Pharmacovigilance Network Specialist
$82.4k - $123.6kVertex Inc.
Job Description General Summary: The International Pharmacovigilance (PV) Specialist is responsible for supporting management of the GPS International PV structure. The International PV Specialist works with a moderate level of supervision and helps troubleshoot problems and improve internal procedures, to ensure compliance with applicable regulatory requirements. Key Duties and Responsibilities: Assists with ensuring that all GPS procedures are compliant with global PV regulations Contributes to vendor oversight activities Supports the oversight of local Qualified Persons for Pharmacovigilance (QPPVs) Researches PV regulations and guidelines Reviews, assesses, and tracks global PV regulatory intelligence Reviews PV agreements which support local and regional PV requirements Works cross-functionally to plan and verify safety database configuration compliance based on PV intelligence and geographic expansion activities Performs compliance impact assessments as assigned Assists with production of presentations concerning safety issues, initiatives, and projects Represents GPS and Vertex regarding patient safety related matters as assigned Regularly responds to cross-functional teams’ and vendor questions Collaborates and builds/fosters relationships cross-functionally and on a global scale with individuals of all levels Provides PV information and guidance to cross- functional teams Performs other duties as assigned May also: Collect, analyze and utilize data and feedback / share information to identify opportunities to improve relationships cross-functionally, working effectively and lead business-wide improvements Liaise between GPS and members of International teams Communicate and coordinate activities and bridge alignment Triage and escalate patient safety related matters as appropriate Proactively raise awareness and promote GPS activities, policies and best practices Share information for innovative corporate improvement projects as endorsed Knowledge and Skills: Effectively operates in a matrix environment to support cross-functional initiatives Ability to multi-task with sound attention to detail Solid written and verbal communication skills Ability to work under moderate supervision, as well as in a team setting Understands established procedures Ability to adapt and react to change in priorities and effectively manage workload with support from line management Basic understanding of global PV regulatory requirements Proficiency in using Microsoft Office applications required (Word, Excel, and PowerPoint) Education and Experience: Bachelor's degree (or equivalent degree) Typically requires 1 to 3 years of relevant work experience Pay Range: $82,400 - $123,600 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1. Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select 2. Hybrid: work remotely up to two days per week; or select 3. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Remote Company Information Vertex is a global biotechnology company that invests in scientific innovation. 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. 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 View email address on click.appcast.io Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.
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