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Senior Drug Safety Associate

India-Trivandrum
Permanent
Reference: 045860
This vacancy has now expired.
Description
• Recognize, exemplify and adhere to ICON's values which centers 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 (up to approximately 15%) domestic and/or international as applicable • *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 meetings • *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 • Perform other activities as identified and requested by management
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