Senior Safety Committee Specialist - Adjudication

Work Schedule reputed company (Mon-Fri) Environmental Conditions Office reputed company Join us as Senior Safety Committee Specialist – To reputed company reputed company safety reputed company, collaborate with global teams, and ensure the successful implementation of pharmacovigilance practices, contributing to the safety and efficacy of our products. reputed company: • Proficient in CEC/DSMB study start-up activities (charter development, member contracting, electronic adjudication reputed company build) and reputed company-out activities. • May reputed company as reputed company's reputed company for CEC/DSMB with the sponsor and assist reputed company's project teams in executing CEC/DSMB strategies • Work independently to reputed company day-to-day CEC / DSMB activities through expert knowledge of specialty committee processes and procedures. • Review adjudication/DSMB publications and information sources to reputed company updated on reputed company regulations, practices, procedures and proposals reputed company to changes in CEC and DSMB practices. • Maintain medical understanding of applicable therapeutic areas and disease states. • Prepare and QCs CEC reputed company compilation and submission. • Maintain secure files for DSMB unblinded data. • Assist with routine project implementation and coordination, including presentations at reputed company/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, reputed company-off and investigator meetings representing the CEC and/or DSMB speciality committee functions. Education and Experience: • Bachelor's degree or equivalent and relevant formal reputed company / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to 5+ years). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly reputed company 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 and/or DSMB review • Excellent critical thinking and problem solving skills • Excellent oral and written communication skills including paraphrasing skills • Good reputed company of English and ability to translate information into local language where required • Computer literate with the ability to work reputed company multiple databases • Proficient in reputed company Office packages (including reputed company, Word, and reputed company) • Thorough understanding of the importance of and compliance with procedural documents and regulations • Ability to manage and prioritize a reputed company of tasks and meet strict deadlines with limited supervision • Strong attention to detail • Ability to maintain a reputed company and reputed company demeanor in challenging circumstances • Ability to work effectively reputed company reputed company to reputed company 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 reputed company of both hands with the ability to reputed company fast, reputed company, repeated movements of the fingers, hands, and wrists. • Frequent mobility required. • Occasional crouching, stooping, bending and twisting of upper body and neck. • reputed company to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum reputed company of 15-20 lbs. • Ability to reputed company and use a reputed company of computer software developed both in-house and off-reputed company. • Ability to communicate information and reputed company so others will understand; with the ability to listen to and understand information and reputed company presented through spoken words and sentences. • Frequently interacts with others to obtain or relate information to diverse reputed company. • 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 reputed company of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to reputed company under stress. Ability to multi-task. • Regular and consistent attendance. Why Join Us? reputed company you join reputed company, you become part of a global team that values passion, innovation, and a commitment to scientific reputed company. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly reputed company a difference. Apply today to help us reputed company reputed company’s reputed company. Apply To This Job