Associate Director, Patient Safety Clinical Trials/Managed Access Programs page is loaded
Associate Director, Patient Safety Clinical Trials/Managed Access Programs
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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 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 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
Interfaces with relevant stakeholders to ensure program-specific GPS requirements are appropriately addressed
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
Contributes to ongoing development of innovative best practices within GPS
Represents GPS in cross-functional initiatives and meetings
Maintains knowledge of evolving international guidance and regulations for PV, especially regarding ICSR processes and reporting requirements
May have line management responsibilities
Knowledge and Skills:
Direct, in-depth experience with all operational aspects of ICSR processing and reporting
Excellent project management skills with the ability to align internal and external resources
Highly developed interpersonal and communication skills including verbal, written and presentation skills; skilled at conveying technical information and difficult concepts and persuading others to take action
Ability to evaluate and analyze procedural gaps
Experience in direct pre- and post-marketing PV
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
Education and Experience:
Bachelor's degree in life sciences, allied health professional degree, PharmD, M.S.N., or equivalent degree
8 years of experience or the equivalent combination of education and experience
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.
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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 Fortunes 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit
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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 peoples 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.
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