Drug Safety Coordinator

POSITION SUMMARYPerform oversight and/or processing for all types of safety events, and other medically-related project informationServe as a pharmacovigilance (PV) lead for projects providing project management/project management support as designatedServe as support to management in all aspects of departmental activities, including coordination of extra departmental tasks as neededServe as technical expert with regard to all aspects of safety monitoring, per global regulations (i.e. FDA, ICH, EMA)Ensure all ICON, Sponsor, and regulatory timeframes are met for the processing and reporting of safety informationAssist in ensuring the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to Sponsors

JOB FUNCTIONS/RESPONSIBILITIESRecognize, exemplify and adhere to ICON's values which center around our commitment to People, clients and performanceAs a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needsTravel (approximately 10%) domestic and/or internationalComplete all departmental project activities accurately in accordance with ICON SOPs, project specific procedures, regulatory requirements and Sponsor processesProvide oversight and/or review and process safety events (pre-marketing, device and drug) and/or other medically related information per assigned tasks and project specific proceduresProvide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project filesAct as a project manager for assigned projects, liaising with sponsor, and management of timelines and budgets, as appropriateCoordinate and lead project teams as assignedCoordinate functional safety activities in support of project manager on assigned projectsProvide in-depth technical expertisePerform safety review of clinical and diagnostic data as part of case processingGeneration of project specific proceduresSupport development of post-marketing safety activities, such as PSMF, RMP and PBRERSupport QPPV as requiredSupport development of clinical trial activities, such as DSURs, 6-monthly line listings, by liaising with other ICON departments and/or other Sponsor vendorsLiaise with ICON medical monitor, project manager and other departments, as appropriateActively identify out of scope activities and process efficiency/improvement needsReview assigned contracts and coordinate contract amendments/change orders as requiredCoordinate project team and sponsor meetings (including investigator meetings) and teleconferences as requiredAssist with creation, coordination, and/or delivery of training to PVSS staffTrain/mentor Sr. Drug Safety Associate (or as assigned) staffCoordination of interdepartmental activities (e.g. quality control processes, quality assurance (audits), miscellaneous project activities)Completion of weekly and monthly project status reports including quality review findings and metrics, as requiredDevelopment and conduct of safety presentation for start-up meetings, kick-off meetings, investigator meetings and other meetings as assignedParticipate in hiring for new staff as requestedPerform other activities as identified and requested by management