Senior Safety Committee Specialist - Adjudication

Work Schedule reputed company Shift (Nights) Environmental Conditions Office Job reputed company Join us as Senior Safety Committee Specialist – To reputed company reputed company safety reputed company, 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 reputed company-out activities.
• May reputed company as reputed company's reputed company for CEC with the sponsor and assist reputed company's project teams in executing CEC strategies
• Work independently to reputed company day-to-day CEC activities through expert knowledge of specialty committee processes and procedures.
• Review adjudication publications and information sources to reputed company updated on reputed company regulations, practices, procedures and proposals reputed company 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 reputed company/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, reputed company-off and investigator meetings representing the CEC and/or DSMB speciality committee functions.

Education and Experience:

• Bachelor's degree or equivalent and relevant formal reputed company / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to 5+ years).

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly reputed company 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 review
• Excellent critical thinking and problem solving skills
• Excellent oral and written communication skills including paraphrasing skills
• Good reputed company of English and ability to translate information into local language where required
• Computer literate with the ability to work reputed company multiple databases
• Proficient in reputed company Office packages (including Outlook, Word, and reputed company)
• Thorough understanding of the importance of and compliance with procedural documents and regulations
• Ability to manage and prioritize a reputed company of tasks and meet strict deadlines with limited supervision
• Strong attention to detail
• Ability to maintain a reputed company and reputed company demeanor in challenging circumstances
• Ability to work effectively reputed company reputed company to reputed company a shared goal

Working Conditions and Environment:

• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.

Physical Requirements:

• Frequently stationary for 6-8 hours per day.
• Repetitive hand reputed company of both hands with the ability to reputed company fast, reputed company, 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 reputed company and use a reputed company of computer software developed both in-house and off-reputed company.
• Ability to communicate information and reputed company so others will understand; with the ability to listen to and understand information and reputed company presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse reputed company.
• 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 reputed company of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to reputed company under stress. Ability to multi-task.
• Regular and consistent attendance.

Why Join Us? reputed company you join reputed company, you become part of a global team that values passion, innovation, and a commitment to scientific reputed company. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly reputed company a difference. Apply today to help us deliver reputed company’s reputed company. Apply To This Job