Job Description
Work Schedule Standard Office Hours (40/wk) Environmental Conditions Office Job Description Join us as Senior Safety Committee Specialist - Adjudication – To lead complex safety/endpoint projects, collaborate with global teams, and ensure the successful implementation of pharmacovigilance practices, contributing to the safety and efficacy of our products. What You’ll Do: • Proficient in CEC study start-up activities (charter development, member contracting, electronic adjudication system build) and close-out activities. • May act as the company's liaison for CEC with the sponsor and assist the company's project teams in executing CEC strategies • Work independently to perform day-to-day CEC activities through expert knowledge of specialty committee processes and procedures. • Review adjudication publications and information sources to keep updated on current regulations, practices, procedures and proposals related to changes in CEC practices. • Maintain medical understanding of applicable therapeutic areas and disease states. • Prepare and QCs CEC dossier compilation and submission. • Assist with routine project implementation and coordination, including presentations at client/investigator meetings, and review of metrics and budget considerations as they relate to specialty committee activities. • 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 committee functions. Education and Experience: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • Thorough understanding of pathophysiology and the disease process • Strong knowledge of relevant therapeutic areas as required for CEC review • Excellent critical thinking and problem-solving skills • Excellent oral and written communication skills including paraphrasing skills • Good command of English and ability to translate information into local language where required • Computer literate with the ability to work within multiple databases • Proficient in Microsoft Office packages (including Outlook, Word, and Excel) • Thorough understanding of the importance of and compliance with procedural documents and regulations • Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision • Strong attention to detail • Ability to maintain a positive and professional demeanor in challenging circumstances • Ability to work effectively within a team to attain a shared goal Working Conditions and Environment: • Work is performed in an office environment with exposure to electrical office equipment. • Occasional drives to site locations with occasional travel both domestic and international. Physical Requirements: • Frequently stationary for 6-8 hours per day. • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. • Frequent mobility required. • Occasional crouching, stooping, bending and twisting of upper body and neck. • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. • Ability to access and use a variety of computer software developed both in-house and off-the-shelf. • 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. • Frequently interacts with others to obtain or relate information to diverse groups. • 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. • 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. • Regular and consistent attendance. Why Join Us? 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. Apply today to help us deliver tomorrow’s breakthrough.