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.