Jodie Leigh Richter
Drug Safety Manager @ICON plc
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WORK HISTORY
Drug Safety Manager @ICON plc
Support to Drug Safety Management in all aspects of departmental and interdepartmental activities. • Serve as liaison between Administrative, Safety, Management, Regulatory and Database systems teams. • Coordinate daily workflow and task activities within the scope and range of each individual’s role. • Provide mentorship for junior DSA staff. Assist staff in identifying out of scope work. • Guide the creation and coordination of training of an international DSA and administration staff. • Deliver international face to face trainings and web based trainings as required. • Identify extra-departmental, investigational site and sponsor training required to enhance communication, data accuracy and final product delivery. • Serve as technical expert with regard to all aspects of safety monitoring for clinical trials. Provide technical expertise to DSA staff and project safety leads. • Ensure that daily project safety activities are completed in accordance with internal standards and other applicable standards. • Ensure all internal, sponsor, and regulatory time frames are met for the processing and reporting of safety information. • Serve as resource to staff performing start-up activities for new projects. Serve as resource knowledge for ongoing project changes and updates. • Develop, maintain, and document new workflow processes and liaise with external departments, as needed. • Review SSPs, maintain appropriate documentation, and liaise with QA department as necessary prior to management review and approval of SSPs. • Assist Medical Management team with activities. Serve as a resource to medical safety staff with regard to SOPs, SSPs, and other regulations. • Connect, communicate and resolve safety concerns/issues with sponsors, internal team, and investigational sites. • Perform accurate monthly invoicing tasks for a global study • Coordinate database set-up for new protocols, system updates and new user access.
EDUCATION
Eastern University
Bachelor's degree in Applied Nursing Science, Adult Health Nurse/Nursing
Montgomery County Community College
Associate Degree in Applied Nursing Science, Adult Health Nurse/Nursing
SKILLS
ABOUT JODIE LEIGH RICHTER
Self-directed, self-motivated, detail-oriented nursing professional currently working in the pharmacovigilance field seeking a position to broaden my career path coordinating and managing clinical research trails in the drug safety and the medical device industry. My greatest strength lies in my ability to relate and communicate effectively and to translate others learning needs. I enjoy working with diverse populations through business travel and international training opportunities.
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