Job Description
Join Us as an Associate Safety Reporting Specialist – Make an Impact at the Forefront of Innovation
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.
The Associate Safety Reporting Specialist assists in the receipt, submission, and subsequent tracking of expedited and periodic safety reports pertaining to the department's projects. Supports management in producing project metrics as required. Participates in projects and programs relating to safety reporting.
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
What You'll Do
•Receive, prepare, and submit safety reports to applicable parties, ensuring compliance with regulatory timelines and country legislation.
•Track all expedited/periodic safety report submissions, ensuring retention of evidence of submission. Alert your lead and/or line manager to any quality or timeline issues.
•Develop project management skills by acting as support to an assigned lead, and may also lead small projects.
•Liaise with relevant teams around safety reporting tasks and assist the assigned lead as required.
•Run reports and ensure that repositories/systems are maintained with up-to-date contact information. Provide ad hoc administrative support as and when required.
•Ensure regulatory submission files and filing processes are prepared, set up, maintained, and archived as per the organization's WPDs or applicable client SOPs.
•Assist the manager in the collation of metrics.
Education and Experience Requirements
•Bachelor's degree or equivalent and relevant formal academic / vocational qualification
•Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 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
•Basic knowledge of medical terminology
•Good written and verbal communication skills
•Proficiency in Microsoft Office programs and a basic understanding of safety database functionality
•Basic knowledge of procedural documents and working knowledge of global safety reporting requirements (including FDA regulations and guidelines)
•Good organizational and time management skills
•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
•Ability to work effectively within a team
Working Environment
Thermo Fisher Scientific values the health and wellbeing of our employees. Below is listed the working environment/requirements for this role:
•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
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
