Drug Safety Coordinator

POSITION SUMMARY

• Perform oversight and/or processing for all types of safety events, and other medically-related project information
• Serve as a pharmacovigilance (PV) lead for projects providing project management/project management support as designated
• Serve as support to management in all aspects of departmental activities, including coordination of extra departmental tasks as needed
• Serve 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 information
• Assist in ensuring the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to Sponsors

JOB FUNCTIONS/RESPONSIBILITIES

• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, clients and performance
• As 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 needs
• Travel (approximately 10%) domestic and/or international
• Complete all departmental project activities accurately in accordance with ICON SOPs, project specific procedures, regulatory requirements and Sponsor processes
• Provide 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 procedures
• Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files
• Act as a project manager for assigned projects, liaising with sponsor, and management of timelines and budgets, as appropriate
• Coordinate and lead project teams as assigned
• Coordinate functional safety activities in support of project manager on assigned projects
• Provide in-depth technical expertise
• Perform safety review of clinical and diagnostic data as part of case processing
• Generation of project specific procedures
• Support development of post-marketing safety activities, such as PSMF, RMP and PBRER
• Support QPPV as required
• Support development of clinical trial activities, such as DSURs, 6-monthly line listings, by liaising with other ICON departments and/or other Sponsor vendors
• Liaise with ICON medical monitor, project manager and other departments, as appropriate
• Actively identify out of scope activities and process efficiency/improvement needs
• Review assigned contracts and coordinate contract amendments/change orders as required
• Coordinate project team and sponsor meetings (including investigator meetings) and teleconferences as required
• Assist with creation, coordination, and/or delivery of training to PVSS staff
• Train/mentor Sr. Drug Safety Associate (or as assigned) staff
• Coordination 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 required
• Development and conduct of safety presentation for start-up meetings, kick-off meetings, investigator meetings and other meetings as assigned
• Participate in hiring for new staff as requested
• Perform other activities as identified and requested by management