**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** Maintains understanding of methods for recording time spent on project and administrative tasks. Ensures tasks delegated to PVG are accurately completed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific WPDs for assigned projects. Adheres to corporate policies and SOPs/WPDs. Provides medical consultation to team members and answer all project/study related medical questions. Communicates clearly with associates and clients maintaining an open line of communication to ensure all procedures are follow appropriately. Provides safety reporting training on assigned projects/studies, as requested. Medically reviews adverse event and serious adverse event data from all source(solicited, spontaneous, literature, etc) as contracted. Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported in Clinical Trials. Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns. Assists in writing (interpretation of safety data) and/or review of CSR, IND/NDAreport, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete. Handles signal detection activities, scientifically reviews, periodic safety reports, label updates, supports dossier maintenance and risk management activities. Thermo 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 status.