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    Associate Director, Patient Safety Clinical Trials/Managed Access Programs - Boston, MA, United States - Vertex Pharmaceuticals

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    Associate Director, Patient Safety Clinical Trials/Managed Access Programs page is loaded Associate Director, Patient Safety Clinical Trials/Managed Access Programs
    Apply locations Boston, MA time type Full time posted on Posted 3 Days Ago job requisition id REQ-21438 Job Description

    The 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 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.

    Leads and mentors staff on managing the operational PV activities associated with clinical trials and managed access programs
    Provides 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 rules
    Collaborates with International Pharmacovigilance to establish program-specific requirements and ensure compliance with global pharmacovigilance regulations
    Collaborates with GPS Quality, Standards & Training in the identification and remediation of regulatory/compliance risks
    Maintains knowledge of evolving international guidance and regulations for PV, especially regarding ICSR processes and reporting requirements
    May have line management responsibilities
    Excellent project management skills with the ability to align internal and external resources
    Direct experience with external partner and vendor/outsourcing management required
    In-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 worldwide

    Bachelor's degree in life sciences, allied health professional degree, PharmD, M.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 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
    Senior Medical Director, Patient Safety
    locations Boston, MA time type Full time posted on Posted 25 Days Ago Associate Director, Patient Safety Epidemiology
    locations Boston, MA time type Full time posted on Posted 2 Days Ago Patient Safety ICSR Manager

    locations Boston, MA time type Full time posted on Posted 4 Days Ago 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 .

    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.



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