Senior Safety Committee Specialist - Adjudication

Thermo Fisher Scientific • Morrisville, NC

4d

About The Position

Join us as Senior Safety Committee Specialist - Adjudication – To lead complex safety/endpoint projects, collaborate with global 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 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 with the sponsor and assist the company's project teams in executing CEC strategies Work independently to perform day-to-day CEC activities through expert knowledge of specialty committee processes and procedures. Review adjudication publications and information sources to keep updated on current regulations, practices, procedures and proposals related to changes in CEC practices. Maintain medical understanding of applicable therapeutic areas and disease states. Prepare and QCs CEC dossier compilation and submission. 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 committee functions.

Requirements

• 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 individual to meet the requirements of the role.
• Thorough understanding of pathophysiology and the disease process
• Strong knowledge of relevant therapeutic areas as required for CEC 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

Responsibilities

• Proficient in CEC 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 with the sponsor and assist the company's project teams in executing CEC strategies
• Work independently to perform day-to-day CEC activities through expert knowledge of specialty committee processes and procedures.
• Review adjudication publications and information sources to keep updated on current regulations, practices, procedures and proposals related to changes in CEC practices.
• Maintain medical understanding of applicable therapeutic areas and disease states.
• Prepare and QCs CEC dossier compilation and submission.
• 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 committee functions.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees