Senior Safety Committee Specialist - DSMB

Thermo Fisher Scientific•Morrisville, NC

1d•Onsite

About The Position

The Senior Safety Committee Specialist leads complex safety projects, collaborates with global teams, and supports the successful implementation of pharmacovigilance practices that contribute to the safety and efficacy of products. The role specializes in Cardiac Event Committee (CEC) and Data and Safety Monitoring Board (DSMB) activities, including study start-up and close-out, committee coordination, and related project execution. The specialist may serve as the company liaison for CEC/DSMB matters with sponsors and support project teams in implementing committee strategies. The role requires independent management of day-to-day committee processes, keeping current with relevant practices and regulations, maintaining therapeutic-area knowledge, and preparing and quality-checking CEC dossier submissions. It also includes maintaining secure files for DSMB unblinded data and supporting project implementation, client and investigator meetings, metrics, budgets, procedures, and audits. Work is performed in an office environment, with rare driving to site locations and occasional domestic and international travel. The position involves frequent computer use, extended periods of stationary work, frequent mobility and interaction with others, and occasional light-to-moderate lifting.

Requirements

Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 5+ years.
Thorough understanding of pathophysiology and disease processes.
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.
Good command of English and ability to translate information into a local language where required.
Computer literacy and ability to work within multiple databases.
Proficiency in Microsoft Office, 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.
Ability to perform the described physical and computer-related tasks, including frequent stationary work, repetitive hand movements, frequent mobility, and occasional lifting of up to 15–20 lbs.

Responsibilities

Perform CEC/DSMB study start-up activities, including charter development, member contracting, and electronic adjudication system build, as well as close-out activities.
May act as the company's CEC/DSMB liaison with the sponsor and assist project teams in executing CEC/DSMB strategies.
Independently perform day-to-day CEC/DSMB activities using expert knowledge of specialty committee processes and procedures.
Review adjudication/DSMB publications and information sources to stay current on regulations, practices, procedures, and proposed changes to CEC and DSMB practices.
Maintain medical understanding of applicable therapeutic areas and disease states.
Prepare and quality-check 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 related to specialty committee activities.
May assist in preparing departmental and project-specific procedures and processes.
Prepare for and attend audits, kick-off meetings, and investigator meetings while representing CEC and/or DSMB specialty committee functions.