Senior Safety Committee Specialist - Adjudication

Thermo Fisher Scientific • Morrisville, NC

6d

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.

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