Senior Drug Safety Associate

Job Profile

Senior Drug Safety Associate

Job Description Summary

• 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

Job Description

• 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) independently
• Travel domestically and internationally as required
• Perform other activities as identified and requested by management

Requirement

• 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.