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 speciality 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.
- 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.
