Job DescriptionThe Associate Director, Patient Safety Clinical Trials/Managed Access Programs (CT/MAP) is responsible for the oversight of the operational pharmacovigilance (PV) activities associated with clinical trials and managed access programs. This role plans, executes and manages the technical aspects of lndividual Case Safety Report (ICSR) processing and reporting for clinical trials and managed access programs. In addition, this role interfaces with relevant program stakeholders to represent Global Patient Safety (GPS) and ensure compliance with global PV regulations. The Associate Director, Patient Safety CT/MAP will play a key role in managing the GPS activities associated with clinical trials and managed access programs. This role will also serve as subject matter expert in PV, and will be a key contributor to developing and implementing best standards and practices in GPS. This position will also represent GPS in various cross-functional initiatives and therefore, must possess relevant technical PV experience as well as excellent communication and project management skills.Key Duties and Responsibilities:Leads and mentors staff on managing the operational PV activities associated with clinical trials and managed access programsProvides guidance to GPS ICSR processing staff on technical aspects of clinical trials and managed access programs, including configuration of the Global Safety Database and relevant reporting rulesInterfaces with relevant stakeholders to ensure program-specific GPS requirements are appropriately addressedCollaborates with International Pharmacovigilance to establish program-specific requirements and ensure compliance with global pharmacovigilance regulationsCollaborates with GPS Quality, Standards & Training in the identification and remediation of regulatory/compliance risksContributes to ongoing development of innovative best practices within GPSRepresents GPS in cross-functional initiatives and meetingsMaintains knowledge of evolving international guidance and regulations for PV, especially regarding ICSR processes and reporting requirementsMay have line management responsibilitiesKnowledge and Skills:Direct, in-depth experience with all operational aspects of ICSR processing and reportingExcellent project management skills with the ability to align internal and external resourcesHighly developed interpersonal and communication skills including verbal, written and presentation skills; skilled at conveying technical information and difficult concepts and persuading others to take actionAbility to evaluate and analyze procedural gapsExperience in direct pre- and post-marketing PVDirect experience with external partner and vendor/outsourcing management requiredIn-depth understanding of drug development process and drug safety regulatory requirements, including knowledge of safety reporting in clinical trials, post-marketing surveillance, case processing and reporting to regulatory authorities worldwideEducation and Experience:Bachelor's degree in life sciences, allied health professional degree, PharmD, M.S.N., or equivalent degree8+ years of experience or the equivalent combination of education and experienceCompany 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.com.
