06 sep
|
Thermo Fisher Scientific
|
Ciudad de México
06 sep
Thermo Fisher Scientific
Ciudad de México
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join us as Senior Safety Committee Specialist – To lead complex safety projects, collaborate with general teams, and ensure the successful implementation of pharmacovigilance practices, contributing to the safety and efficacy of our products.
What You’ll 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 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 speciality committee functions.
Education and Experience:
• 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 for an i
📌 Senior Safety Committee Specialist (Ciudad de México)
🏢 Thermo Fisher Scientific
📍 Ciudad de México