Patient Safety Medical Director Position Available In Suffolk, Massachusetts

Job Description General Summary:

The Patient Safety Medical Director will provide medical safety expertise for assigned products, pre- and post-approval. The role will optimize patient safety of Vertex products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe through the effective and timely completion of Safety activities through the product life cycle.

Key Duties and Responsibilities:

Provides medical safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development) Responsible for the safety assessment activities of assigned products under the supervision of a Global Patient Safety (GPS) Disease-area Safety Head Autonomously monitors the benefit risk profile of assigned products/portfolio in an ongoing fashion and in accordance GPS processes and procedures Leads the safety and risk management processes including chairing assigned Disease-area Safety and Product Safety Teams Leads the development of safety-related responses to Safety queries from health authorities Identifies, prioritizes and analyzes clinical safety signals, in accordance with GPS procedures Leads ongoing review of emerging safety data from various sources including single case reports, published literature, aggregate reports, and other sources Represents department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues Conducts medical evaluation of relevant safety-related information from Toxicology, Non-Clinical studies, as well as Product Quality complaints, as needed Participates in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans Participates in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports Contributes to the preparation and review of periodic reports (DSUR, PSUR, PADER) contributing medical strategy and expertise to content, authoring applicable analysis and content Reviews and provides medical content as needed, for key study-related documents, e. g.

IB, ICF, IDMC

Charter Contributes to departmental development activities including SOP and Work Instructions development Provides guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective Contributes to Partner/Affiliate agreements and interactions, as needed Provides effective and relevant review of complex documents

Knowledge and Skills:

Broad and extensive knowledge of medicine, pharmacovigilance and relevant regulations Extensive evidence of effective delivery of high quality safety relevant documents. Broad knowledge of relevant concepts in data management and systems, pharmacoepidemiology and statistics, including the interpretation of complex data and information Communicates complex issues in an understandable, effective and relevant manner. Strong influencing skills with the ability to explain and defend positions regarding significant issues in the face of opposition Strategic focus regarding activities, with proactive planning and prioritization skills. Takes ownership of appropriate issues and appropriately delegates Technical expertise in pharmacovigilance and clinical safety Excellent analytical and problem solving skills, with sound autonomy and applied judgment Experience with Regulatory Agency and key stakeholder interactions Experience with ICSR case review and Aggregate Safety analysis and reports Experience with key Global PV/Regulatory approval activities, including

NDA/MAA, RMP and REMS Education and Experience:

MD degree or equivalent (e. g. , DO or MB) required 5 years of experience with relevant experience in Safety/Pharmacovigilance, or the equivalent combination of education and experience

Pay Range:

$200,000 – $300,000

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:

Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as: 1.

Hybrid:

work remotely up to two days per week; or select 2.

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. 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 ApplicationAssistance@vrtx.com 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 www.vrtx.com 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.