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.
What You’ll Do:
Proficient in CEC/DSMB 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/DSMB with the sponsor and assist the company's project teams in executing CEC/DSMB strategies
Work independently to perform day-to-day CEC / DSMB activities through expert knowledge of specialty committee processes and procedures.
Review adjudication/DSMB publications and information sources to keep updated on current regulations, practices, procedures and proposals related to changes in CEC and DSMB practices.
Maintain medical understanding of applicable therapeutic areas and disease states.
Prepare and QCs CEC dossier compilation and submission.
Maintain secure files for DSMB unblinded data.
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 and/or DSMB specialty 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 and/or DSMB 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.
Rarely 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.
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