<p style="text-align:left"><b>Work Schedule</b></p>Standard (Mon-Fri)<p style="text-align:inherit"></p><p style="text-align:left"><b>Environmental Conditions</b></p>Office<p style="text-align:inherit"></p><p style="text-align:left"><b><u>Job Description</u></b></p><p style="text-align:inherit"></p><p>Join us as Senior Safety Committee Specialist – To lead complex safety projects, collaborate with global teams, and ensure the successful implementation of pharmacovigilance practices, contributing to the safety and efficacy of our products.<br><br>What You’ll Do:<br>• Proficient in CEC/DSMB study start-up activities (charter development, member contracting, electronic adjudication system build) and close-out activities.<br>• May act as the company's liaison for CEC/DSMB with the sponsor and assist the company's project teams in executing CEC/DSMB strategies<br>• Work independently to perform day-to-day CEC / DSMB activities through expert knowledge of specialty committee processes and procedures.<br>• Review adjudication/DSMB publications and information sources to keep updated on current regulations, practices, procedures and proposals related to<br>changes in CEC and DSMB practices.<br>• Maintain medical understanding of applicable therapeutic areas and disease states.<br>• Prepare and QCs CEC dossier compilation and submission.<br>• Maintain secure files for DSMB unblinded data.<br>• Assist with routine project implementation and coordination, including presentations at client/investigator meetings, and review of metrics and budget<br>considerations as they relate to specialty committee activities.<br>• May assist in the preparation of departmental and project-specific procedures and processes, prepare for and attend audits, kick-off and investigator meetings representing the CEC and/or DSMB speciality committee functions.<br><br>Education and Experience:<br>• Bachelor's degree or equivalent and relevant formal academic / vocational qualification<br>• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).<br><br>In some cases, an equivalency, consisting of a combination of appropriate education, training<br>and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.<br><br>Knowledge, Skills and Abilities:<br>• Thorough understanding of pathophysiology and the disease process<br>• Strong knowledge of relevant therapeutic areas as required for CEC and/or DSMB review<br>• Excellent critical thinking and problem solving skills<br>• Excellent oral and written communication skills including paraphrasing skills<br>• Good command of English and ability to translate information into local language where required<br>• Computer literate with the ability to work within multiple databases<br>• Proficient in Microsoft Office packages (including Outlook, Word, and Excel)<br>• Thorough understanding of the importance of and compliance with procedural documents and regulations<br>• Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision<br>• Strong attention to detail<br>• Ability to maintain a positive and professional demeanor in challenging circumstances<br>• Ability to work effectively within a team to attain a shared goal<br><br>Working Conditions and Environment:<br>• Work is performed in an office environment with exposure to electrical office equipment.<br>• Occasional drives to site locations with occasional travel both domestic and international.<br><br>Physical Requirements:<br>• Frequently stationary for 6-8 hours per day.<br>• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.<br>• Frequent mobility required.<br>• Occasional crouching, stooping, bending and twisting of upper body and neck.<br>• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.<br>• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.<br>• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.<br>• Frequently interacts with others to obtain or relate information to diverse groups.<br>• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.<br>• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.<br>• Regular and consistent attendance.<br><br>Why Join Us?<br>When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.<br><br>Apply today to help us deliver tomorrow’s breakthrough.</p><p></p><p></p><p></p><p></p>
