Work as Aggregate safety reports scientist @ Accenture
Job Location: Chennai
Job Number: J3254
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- Job description
Overall Purpose of the job
Responsible for activities for creating Aggregate Safety Reports to achieve the service level agreements.
Responsibilities/Authorities
• Review, write and refine the draft of Aggregate Safety Report.
• Conduct analysis of single cases to determine the relevant section in aggregate reports
• Create all documents in accordance to all applicable Standard Operating Procedures (SOPs), and conventions.
• Plan, organize, and manage daily work to meet service level timelines and deliverables.
• Work with the Aggregate Safety Reporting lead to escalate issues or tasks outside the normal scope of work.
• Attend a kick-off meeting and regular teleconferences with client partners during the preparation of Aggregate Reports;
• Provide relevant client persons with draft line listings and/or summary tabulations for new EU Aggregate Reports by the Day.
• After completion of the relevant sections and other requirements of Aggregate Reports, provide client with the initial draft of Aggregate Reports for scientific and medical review by the Day.
• Provide clients with the final draft of the sections of EU Aggregate Reports;
• Provide client with a summary of the most frequent and most Serious Adverse Events, grouped per system organ class or Serious Adverse Experiences, grouped per body system, as specified per client Guidelines and SOPs;
• Provide client with an overview of the Cases that resulted in death as specified per client Guidelines and SOPs.
• Promote/participate, as appropriate, internal and external safety activities including regulatory audits
• Mentor colleagues in area of expertise when assigned
Educational Requirements :
1. Degree in Healthcare Science Preferred, minimum requirement post graduate degree in life science .
2. Background in clinical sciences is preferred. Minimum of 1 years experience in clinical domain.
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