Patient Safety Epidemiology Associate Director

Job DescriptionGeneral Summary:The Patient Safety Epidemiology Associate Director leads safety and regulatory epidemiology activities for Vertex products across multiple therapeutic areas and throughout all phases of lifecycle. This includes execution of post-marketing regulatory study research strategies, leading comprehensive epidemiologic feasibility assessments, development of epidemiologic study designs, overseeing study implementation, interpretation of findings and communication to internal and external audiences.Key Duties and Responsibilities:Major contributor and driver to the company safety risk management, signal detection, benefit/risk assessments, and post-marketing regulatory research strategiesExpected to research the epidemiology of specific disease areas and events of interest, lead evaluation of data sources and data collection approaches, apply subject matter expertise in the design of observational studies, develop epidemiology sections for regulatory documents, and lead the post-marketing regulatory research strategy implementationEffectively communicates safety and regulatory epidemiologic strategy to product teamsLeads all stages of the design and implementation of regulatory post-marketing studies: from feasibility assessments, development of study designs and protocols, and execution of studies, to communication and dissemination of results to internal and external (e.g., Regulatory Agencies, scientific communities) stakeholdersContributes to company publications strategy via development of conference abstracts, presentations, peer-reviewed manuscripts based on the findings of epidemiological studiesLeads the development of epidemiology sections for Risk Management Plans (EU RMP, REMS, etc.) and other regulatory filings (NDA, PSUR, etc.) for products throughout lifecycleLeads systematic and targeted epidemiologic literature reviews to support safety evaluation and / or post-marketing research strategiesSupports signal detection analyses of safety reporting system databases (FAERS, Vigibase) or other sources (e.g. Sentinel)Leads study execution teams for post-marketing regulatory studiesActively participates at strategic meetings including Disease Area Safety Teams and Global Patient Safety staff meetingsCollaborates cross-functionally to support company strategy for observational research, integrating innovative study methodologiesMay supervise interns and / or contractorsKnowledge and Skills:Specialized knowledge in pharmacoepidemiologic methods, pharmacovigilance regulations, and specific therapeutic areasSpecialized knowledge of study design methodology in general medicine and clinical practice, evidenced by experience in designing/implementation of epidemiology studiesStrong knowledge in pharmacovigilance guidelines and regulationsExcellent verbal and written communication skills, including experience with scientific presentations and peer-reviewed publications, to translate epidemiologic research methods and results to diverse audiencesExcellent independent decision-making skillsStrong project management skillsProven ability to build strong collaborative relationships with stakeholders and business partners and to work effectively in a diverse matrix environmentEducation and Experience:PhD in epidemiology is requiredTypically requires 5 years of experience in pharmaceutical/biotechnology industry, CRO, or academic setting or the equivalent combination of education and experiencePay Range:$0 - $0Disclosure 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-EligibleFlex 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 select2. Hybrid: work remotely up to two days per week; or select3. 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-RemoteCompany 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 View email address on click.appcast.io: Boston, MAType: Full time