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.