.**Work Schedule**Standard (Mon-Fri)**Environmental Conditions**OfficeAt 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.**Summarized Purpose**:Performs and may oversee day-to-day Pharmacovigilance (PV) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Optimally collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third party vendors.**Key responsibilities**:- Works independently to perform day-to-day PV activities. May participate in on[1]call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.- Operates in a lead capacity. Provides assistance in the development of program and departmental procedural documents. May prepare for and attend audits. Mentors less expert staff. Reviews regulatory/pharmacovigilance publications and information sources t- keep updated on current regulations, practices, procedures and proposals. Maintains medical understanding of applicable therapeutic area and disease states. Reviews cases entered for quality, consistency and accuracy, including review of peer reports.- Responsible for routine project implementation and coordination (e.G., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations.**Keys to Success**:**Education and Experience**:Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
