Medical Director, Patient Safety

Job DescriptionGeneral 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 HeadAutonomously monitors the benefit risk profile of assigned products/portfolio in an ongoing fashion and in accordance GPS processes and proceduresLeads the safety and risk management processes including chairing assigned Disease-area Safety and Product Safety TeamsLeads the development of safety-related responses to Safety queries from health authoritiesIdentifies, prioritizes and analyzes clinical safety signals, in accordance with GPS proceduresLeads ongoing review of emerging safety data from various sources including single case reports, published literature, aggregate reports, and other sourcesRepresents department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issuesConducts medical evaluation of relevant safety-related information from Toxicology, Non-Clinical studies, as well as Product Quality complaints, as neededParticipates in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plansParticipates in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study ReportsContributes to the preparation and review of periodic reports (DSUR, PSUR, PADER) contributing medical strategy and expertise to content, authoring applicable analysis and contentReviews and provides medical content as needed, for key study-related documents, e. g. IB, ICF, IDMC CharterContributes to departmental development activities including SOP and Work Instructions developmentProvides guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspectiveContributes to Partner/Affiliate agreements and interactions, as neededProvides effective and relevant review of complex documentsKnowledge and Skills:Broad and extensive knowledge of medicine, pharmacovigilance and relevant regulationsExtensive 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 informationCommunicates 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 oppositionStrategic focus regarding activities, with proactive planning and prioritization skills.Takes ownership of appropriate issues and appropriately delegatesTechnical expertise in pharmacovigilance and clinical safetyExcellent analytical and problem solving skills, with sound autonomy and applied judgmentExperience with Regulatory Agency and key stakeholder interactionsExperience with ICSR case review and Aggregate Safety analysis and reportsExperience with key Global PV/Regulatory approval activities, including NDA/MAA, RMP and REMSEducation and Experience:MD degree or equivalent (e. g. , DO or MB) requiredTypically requires 5 years of experience with relevant experience in Safety/Pharmacovigilance, or the equivalent combination of education and experienceWe’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work:1. Hybrid and work remotely up to two days per week; or select2. On-Site and work 5 days per week with ad hoc flexibility.  #LI-AR1  #LI-HybridFlex Designation:Hybrid-Eligible Or On-Site EligibleFlex 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 select2.    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 InformationVertex 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.comSummaryLocation: Boston, MAType: Full time