Sr Safety Reporting Specialist

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join us as Senior Safety Reporting Specialist – To lead and oversee the preparation of complex safety reports, ensure compliance with international pharmacovigilance regulations, and drive continuous improvement in our reporting processes to safeguard patient health. What You’ll Do: • Receive, prepare and submit safety reports to applicable parties. Ensure that all reports are compliant with regulatory timelines and country legislation and monitor this on a regular basis. • Lead large scale projects effectively, ensuring safety reports are submitted in accordance with the agreed processes and regulatory timelines. • Provide input and feedback to aid the development of program and departmental procedural documents. • Sharing ideas and suggestions with team members. Take an active role in the development and implementation of ideas and suggestions. • Liaise with relevant departments around safety reporting tasks and attends various meetings as required. • Provide input, feedback and guidance to other team members and mentors new starters. • Produce metrics and have some involvement in financial project. 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 5+ 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: • Excellent knowledge of medical terminology • Excellent Microsoft Office skills and good understanding of database functionality • Excellent knowledge of procedural documents and thorough understanding of global safety reporting requirements • Good time management and multi-tasking skills • Strong attention to detail • Ability to influence at all levels of the organization • Ability to work well in a collaborative team environment • Demonstrated initiative and utilizes persuasion and negotiation skills • Excellent critical thinking and problem-solving abilities • Ability to apply knowledge, skills, and expertise to assist lower-level colleagues in safety reporting activities 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.