Safety Reporting Specialist
Safety Reporting Specialist
Posted on :
23-08-2025
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1 Vacancy
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Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
At Thermo Fisher Scientific youll 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 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 departments 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 in producing metrics and alerts manager to any quality or timeline on project teams and may lead projects of small to moderate scope. Provides training and support to other team administrative tasks such as filing and the maintenance of safety reporting systems and with various departments around safety reporting tasks and the setting up of client in audits where required and performs testing activities as ideas and suggestions with team members ensuring effective communication and participates in process improvement to Success: EducationBachelors degree or equivalent and relevant formal academic / vocational qualification ExperiencePrevious 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 Skills AbilitiesStrong knowledge of medical terminologyGood written and verbal communication skillsGood Microsoft Word and Excel skills and solid understanding of safety database functionalitySolid 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 resultsStrong attention to detail and accuracy with orientation toward careful and meticulous workPossess the maturity to handle sensitive information and data effectivelyAbility to interact effectively with all levels of the organizationStrong critical thinking and problem-solving skillsWork 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 to work upright and stationary for typical working to use and learn standard office equipment and technology with to perform successfully under pressure while prioritizing and handling multiple projects or require travel. (Recruiter will provide more details.)BenefitsWe offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values - Integrity Intensity Innovation and Involvement - working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory with PPD part of Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued. Apply today! Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example this may include individuals requiring assistance because of hearing vision mobility or cognitive impairments. If you are a job seeker with a disability or assisting a person with a disability and require accessibility assistance or an accommodation to apply for one of our jobs please submit a request by telephone at 1-*. Please include your contact information and specific details about your required accommodation to support you during the job application process.*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes such as not being able to get into the career website following up on an application or other non-disability related technical issues will not receive a response.Required Experience:
Unclear Seniority
Employment Type
Full-Time
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