Safety Reporting Specialist

Work Schedule

Standard (Mon-Fri)

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.