Senior Safety Committee Specialist DSMB

Work Schedule

Environmental Conditions

Job Description

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 Youll 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 companys liaison for CEC/DSMB with the sponsor and assist the companys 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.

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 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

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.