Skip to main content

Global Patient Safety Clinical Trials/Managed Access Programs (CT/MAP) Manager

Overview The Global Patient Safety Clinical Trials/Managed Access Programs (CT/MAP) Manager supports the oversight of the operational pharmacovigilance (PV) activities associated with clinical trials and managed access programs. This position supports the technical aspects of Individual Case Safety Report (ICSR) processing and reporting for clinical trials and managed access programs. This position interfaces with relevant program stakeholders to represent Global Patient Safety (GPS) and ensure compliance with global PV regulations. Responsibilities
•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 (e.g. Vertex Regulatory Affairs, Vertex Medical Affairs) to ensure program specific GPS requirements are appropriately addressed

•Collaborates with GPS International PV 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

•Promotes a culture of high performance and accountability

•Maintains currency with evolving international guidance and regulations for PV, especially regarding ICSR processes and reporting requirements
Requirements
•B.S. (or equivalent) in life sciences or allied health professional degree with 5+ years of direct pre and post-marketing PV experience or related experience

•Hands-on experience with all operational aspects of ICSR processing and reporting preferred

•Excellent project management skills with the ability to align internal and external resources

•Possess a strong sense of responsibility, ability to work autonomously, and be a strong team player

•Ability to react constructively in a high-energy and fast paced environment

•Excellent interpersonal and communication skills including verbal/written

•Ability to evaluate and analyze procedural gaps
TSP Career Page Category Clinical and Healthcare

Global Patient Safety Clinical Trials/Managed Access Programs (CT/MAP) Manager

TSP
Boston, MA
Full Time

Published on 06/25/2020