Senior Safety Committee Specialist - DSMB

About the role

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.

Responsibilities

• 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

Qualifications

• 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

Skills

• 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

• 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
• Standard schedule: Monday–Friday

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.