Senior Drug Safety Associate【関西窓口】
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・Perform case processing for serious adverse events serious and non serious adverse drug reactions and other medically related project information such as adverse events of special interest and clinical endpoints
・Ensure all ICON Sponsor and regulatory timeframes are met for the processing and reporting of safety information
・Ensure the completion of all departmental project activities accurately in accordance with ICON standards regulatory requirements and contractual obligations to Sponsors
・Complete all departmental project activities accurately in accordance with ICON SOPs Study Specific Procedures regulatory requirements and Sponsors processes
・Review and process serious adverse events spontaneously reported adverse reactions and/or other medically related information per assigned tasks and study specific procedures
・Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files
・Perform safety review of clinical and diagnostic data
・Liaise with investigational site reporter and/or Sponsor as necessary regarding safety issues
・Attend project team meetings and teleconferences as required
・Serve a resource for investigational sites and ICON personnel on safety related issues
・Liaise with Sponsor and attend Sponsor meetings as required
・Liaise with investigational site reporter and/or Sponsor as necessary regarding safety Issues
・Liaise with ICON project manager and other departments as appropriate
・Identify out of scope activities in conjunction with the MSS Functional Lead
・Train/mentor newly hired DSA staff as requested
・Assist with coordination of interdepartmental activities （e.g. listing review quality control quality assurance （audits） miscellaneous project activities）
・Generate study specific procedures for contracted departmental services
・Assist management with weekly and monthly project status reports
・Assist with generation of regulatory reports as necessary to ensure regulatory compliance.
・Conduct safety presentations for start up meetings Investigator meetings and other meeting serve as lead DSA on all （including global） medical or safety projects as assigned
・Actively identify out of scope activities in conjunction with the MSS Functional Lead and/or Clinical Project Manager
・Assist the MSS Functional Lead （e.g. Medical Monitor）
・At least 4 years of Drug Safety experience
・Native level Japanese and High business level English
・With a science degree pharmacy or nursing background or equivalent you will have previous experience in a drug safety environment together with strong knowledge of medical terminology.
・You will have knowledge of drug safety databases preferably ARGUS.
・You will have the ability to produce high quality work with meticulous attention to detail.
600万円 - 900万円