(Senior) Safety Reporting Specialist

Job Description

Work Schedule Environmental Conditions At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Our detailed, goal-oriented Pharmacovigilance colleagues manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring. As part of your work with beginning-to-end trial experience, you will expand your knowledge and experience working on clinical trials through every stage of drug development. This includes management and oversight of all contracted services. Discover Impactful Work: As a Safety Reporting Specialist, you will be responsible for receipt, submission, and subsequent tracking of expedited and periodic safety reports pertaining to the department’s projects. You will assist management in producing project metrics as required. You will also be involved in projects and programs relating to safety reporting and may take a lead role on projects. A day in the Life: Receives, prepares and submits safety reports to applicable parties. Escalates to lead and/or line manager if any issues are encountered. Ensures reports are submitted in compliance with regulatory timelines and country legislation. Assists in producing metrics and alerts manager to any quality or timeline issues. Participates on project teams and may lead projects of small to moderate scope. Provides training and support to other team members. Performs administrative tasks such as filing and the maintenance of safety reporting systems and information. Liaises with various departments around safety reporting tasks and the setting up of client accounts. Participates in audits where required and performs testing activities as needed. Shares ideas and suggestions with team members ensuring effective communication and participates in process improvement initiatives. Keys to Success: Education Bachelor's degree or equivalent and relevant formal academic / vocational qualification Experience Previous experience that provides 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, 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 Work Environment Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel. (Recruiter will provide more details.) Show more Show less