Career for Drug Safety Associate in Icon Clinical Research

ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development – from compound selection to Phase I - IV clinical studies ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.

Post: Drug Safety Associate

Job 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 10%) 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

• Attend project team meetings and teleconferences as required

• Serve a resource for investigational sites and ICON personnel on safety-related issues

• Assist with training/mentoring newly hired DSA staff, as requested

• Assist with identifying out of scope activities in conjunction with the MSS Functional Lead

• Assist with generation of study specific procedures

• Liaise with Sponsor and attend Sponsor meetings, as required

• Perform safety review of clinical and diagnostic data

• Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues

• Liaise with ICON project manager, and other departments, as appropriate

• Assist the MSS Functional Lead under supervision

• Act as lead DSA for local or regional projects

• Perform other activities as identified and requested by management

 

Additional Information:
Education: Pharma graduates
Location: Chennai

Industry Type: Pharma/ Biotech/Clinical Research
Reference: 048166
End Date: 10th January, 2018

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