Senior/Principal Drug Safety Specialist (Night Shift)

Work ScheduleThird Shift (Nights)Environmental ConditionsOfficeJob DescriptionJoin Us as a Senior Safety Specialist – Make an Impact at the Forefront of InnovationWe 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.As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in patient safety. As a Senior Safety Specialist, you'll perform and may oversee day-to-day Pharmacovigilance (PV) activities within a highly regulated environment driven by strict timelines. Your responsibilities will include, but are not limited to, the collection, monitoring, assessment, evaluation, research, and tracking of safety information. You will effectively collaborate with various parties such as project team members, client contacts, investigators, adverse event reporters, and third-party vendors.What You’ll Do:Works independently to perform day-to-day PV activities. May participate in on-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 experienced staff.Reviews regulatory/pharmacovigilance publications and information sources to 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 and Post Approval, including presentations at client meetings, and review of metrics and budget considerationsEducation and Experience Requirements: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).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 and Abilities:Thorough understanding of pathophysiology and the disease processStrong knowledge of relevant therapeutic areas as required for processing AEsExcellent critical thinking and problem solving skills with ability to evaluate and escalate appropriatelyProficient at complex clinical study administration including budget activities and forecastingExcellent oral and written communication skills including paraphrasing skillsGood command of English and ability to translate information into local language where requiredComputer literate with the ability to work within multiple databasesProficient in Microsoft Office products (including Outlook, Word, and Excel)Thorough understanding of the global regulatory requirements and the importance of and compliance with procedural documents and regulationsAbility to manage and prioritize a variety of tasks and meet strict deadlines with limited supervisionStrong attention to detailAbility to maintain a positive and professional demeanor in challenging circumstancesAbility to work effectively within a team to attain a shared goalWorking Conditions and Environment:Work is performed in an office environment with exposure to electrical office equipmentDaily exposure to high pressure and intense concentrationDaily interactions with clients/associatesLong, varied hours on occasionTravel required on occasion domestic and/or internationalWhy Join Us?When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.Apply today to help us deliver tomorrow’s breakthroughs.