Drug Safety Associate

Career Level: Experienced (Non-Manager) Location: Waltham, MA 02451           Job Description: PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, medical marketing and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Headquartered near Boston, Massachusetts, PAREXEL operates in 55 locations throughout 43 countries around the world, and has over 6,315 employees. For more information about PAREXEL International visit www.PAREXEL.com Drug Safety AssociateAs a Drug Safety Associate you will be part of a global medical team where you will have the opportunity to make a large impact on the implementation of complex, multi-center clinical trials. In this office based role you will be responsible for the processing of Serious Adverse Events from Phase 1 to Phase IV clinical trials according to FDA guidelines. This role involves interacting with internal and external team members while managing and leading complex projects in all therapeutic areas. Perform tasks unique to each sponsor while working in collaboration with medical monitors, project managers, Clinical, Data Management, and Medical Writing. This is a dynamic and exciting work environment which involves multiple databases, study start-up, creating procedures, writing adverse event narratives, following up with sites for data collection, clinical endpoints, regulatory reporting, and event tracking. The Drug Safety Associate role provides tremendous learning opportunities.This position can be filled in either the RTP Durham, NC or Waltham, MA office Education: Education: BA/BS in health-related field; prefer BSNMinimum Work Requirements: 3 years clinical experience, minimum one year of clinical research experience preferred but not required Skills: Strong interpersonal and communication skills; expertise in strong database management skills and computer applications; strong writing skills; a good working knowledge of medical terminology and standard medical practice, as well as the ability to digest and apply new knowledge regarding disease entities and pharmaceutical development as related to specific clinical trials. The ability to communicate clearly and precisely, both orally and in writing, is essential, along with the ability to research information and prepare written documents. A keen ongoing interest in medicine, pharmaceuticals, and regulatory affairs is essential for maintaining quality performance in this position, and continuing education in these areas is encouraged. RESPOND HERE! Respond immediately by accessing the following dedicated online response form which will allow you to cut and paste your resume. This form will go directly and immediately to the hiring authority for this position. Access the online response form at: http://sh.webhire.com/servlet/resp/rf?jobid=2175737&boardid=749