Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

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.

• Receives, prepares and submits safety reports to applicable parties. Ensures reports are submitted in compliance with regulatory timelines and country legislation.
• Alerts manager to any quality or timeline issues and takes a proactive approach in the identification and resolution of such issues.
• Leads projects and programs and provides mentorship and support to other team members.
• Leads large scale projects effectively, ensuring safety reports are submitted in accordance with the agreed processes and regulatory timelines. Provides training and support to other team members.
• Performs administrative tasks such as filing and the maintenance of safety reporting systems and information.
• Produces metrics and has some involvement in financial project.
• 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

• 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 successfully with all levels of the organization
• Strong critical thinking and problem-solving skills