.Safety Scientist II (Client-Dedicated) - 6 months contract with possible extension 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.Our detailed, goal-oriented team members 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 tasks.A Day in the Life:Responsible for the planning, coordination and delivery of signal detection and product safety scientist activities, with a focus on tasks which are low to high in complexity or which concern low to high complexity products. Additionally supports activities including generation, review, and presentation of aggregate safety data, mentoring of more junior colleagues, development of processes/tools/systems, and may serve as lead on smaller FSP-type projects.Essential Functions:Serves as a creator/contributor for signal detection and product safety scientist tasks.Leads and performs safety signal management activities including detection, validation, prioritization, evaluation, confirmation or refutation, and the tracking of risk mitigation and minimization actions using Oracle Empirica Signal and Topic.Performs ongoing review of emerging safety data from various sources including individual case safety reports, published literature, aggregate reports, and other sources.Effectively lead, oversee and participate in the planning, preparation and review of periodic safety reports (e.G. DSUR, PSUR, PADER).Assist in assessment of medical safety data for assigned products, development and execution of safety signal and benefit-risk management strategies and closely collaborate with stakeholders.Participate in the presentation and analysis of safety data from on-going and completed clinical trials and from post-marketing sources.Prepare data for and actively participate in safety governance processes.As needed, review and provide safety input, for key study-related documents, e.G. protocols, Investigator's Brochure (IB), or Informed Consent Form (ICF).Conducts quality review for signal detection and product safety scientist tasks which are low to high in complexity, or which concern low to high complexity products.Advises clients on safety related issues.Supports training and mentoring of junior colleagues.Contributes to development of processes, tools and systems.Ensures that tasks are conducted in accordance with company policies and procedures, contractual agreements, and applicable regulations.Participates in departmental initiatives; Serves as a subject matter expert in designated area