FSP Safety Reporting Specialist (Night Shift)

JOB DESCRIPTION

Work Schedule

Third Shift (Nights)

Environmental Conditions

Office

Job Description

Join us as Safety Reporting Specialist – To manage and coordinate the production of regulatory and safety reports, ensure accurate and timely documentation of adverse events, and support compliance with global pharmacovigilance requirements.

What You’ll Do:
• Receive, prepare and submit safety reports to applicable parties. Escalate to lead and/or line manager if any issues are encountered. Ensure reports are
submitted in compliance with regulatory timelines and country legislation.
• Assist in producing metrics and alerts managers to any quality or timeline issues.
• Participate in project teams and may lead projects of small to moderate scope.
• Provide training and support for other team members.
• Perform administrative tasks such as filing and the maintenance of safety reporting systems and information.
• Liaise with various departments around safety reporting tasks and the setting up of client accounts.
• Participating in audits where required and performing testing activities as needed.
• Share ideas and suggestions with team members ensuring effective communication and participates in process improvement initiatives.

Education and Experience:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience to provide the knowledge, skills, and abilities to perform the job (comparable to 2+ 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:
• Strong knowledge of medical terminology
• Good written and verbal communication skills
• Good Microsoft Word and Excel skills and solid understanding of safety database functionality
• Solid knowledge of procedural documents and working knowledge of global safety reporting requirements (including FDA regulations and guidelines)
• Ability to juggle multiple tasks while still delivering high quality results
• Strong attention to detail and accuracy with orientation toward careful and meticulous work
• Possess the maturity to handle sensitive information and data effectively
• Ability to interact effectively with all levels of the organization
• Strong critical thinking and problem-solving skills

Working Conditions and Environment:
• Work is performed in an office/ laboratory and/or a clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required such as protective eyewear, garments and gloves.

Physical Requirements:
• Ability to work in an upright and /or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Frequent mobility required.
• Occasional crouching, stooping, with frequent 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 access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.

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. You’ll 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 tomorrow’s breakthrough.