Senior Safety Committee Specialist - DSMB

Thermo Fisher Scientific•Morrisville, NC

4d•Onsite

About The Position

The Senior Safety Committee Specialist leads complex safety projects and collaborates with global teams to support the implementation of pharmacovigilance practices and contribute to product safety and efficacy. The role manages day-to-day Cardiac Event Committee (CEC) and Data Safety Monitoring Board (DSMB) activities, supporting study start-up and close-out, committee strategy execution, and sponsor and project-team coordination. It also supports dossier preparation, secure management of unblinded DSMB data, project implementation, meetings, audits, and process development. The position is performed in an office environment, with occasional domestic and international travel and rare driving to site locations. It requires frequent stationary work, computer use, mobility, occasional upper-body bending and twisting, and light to moderate lifting of up to 15–20 pounds. The role involves independent work, multiple periods of intense concentration, changing demands, and the ability to perform under stress and manage multiple tasks.

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 or more years; an appropriate combination of education, training, and directly related experience may be considered equivalent.
Thorough understanding of pathophysiology and disease processes.
Strong knowledge of relevant therapeutic areas 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 with 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 varied 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.

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 serve as the company's CEC/DSMB liaison with sponsors 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 and 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-control CEC dossier compilation and submission.
Maintain secure files for DSMB unblinded data.
Assist with routine project implementation and coordination, including presentations at client and investigator meetings and review of metrics and budget considerations related to specialty committee activities.
May assist with preparing departmental and project-specific procedures and processes.
Prepare for and attend audits, kick-off meetings, and investigator meetings, representing CEC and/or DSMB specialty committee functions.