Senior Safety Committee Specialist Adjudication

Work Schedule

Environmental Conditions

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 Youll Do:
Proficient in CEC study start-up activities (charter development member contracting electronic adjudication system build) and close-out activities.
May act as the companys liaison for CEC with the sponsor and assist the companys 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:
Bachelors 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. Youll 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 tomorrows breakthrough.