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Safety Records Coordinator
Ref No.: 18-15027
Location: Summit, New Jersey
Position Type:Contract
Start Date / End Date: 10/22/2018 to 04/20/2019
Sunrise System Inc. is currently looking for Safety Records Coordinator in Summit, NJ with one of our top client.
Job Title: Safety Records Coordinator
Job Id: 18-15027
Location: Summit, NJ 07901
Duration: 6 months
Position Type: Hourly contract Position (W2 only)
 
Job Description
  • See additional attachment as the graphics could not be populated in JD field.
  • Deviations from defined process; Root cause analysis of performance metrics;
  • Interpretation of regulatory requirements;
  • Adhering to process and process amendments to permit worldwide regulatory compliance;
  • Operational SOPs and WPs 
Purpose
  • To coordinate the receipt and initial management of adverse event reports and execute the distribution and tracking of adverse event follow up materials.
  • Key Activities:
  • Coordinate the receipt of AE case reports, specifically: 
Retrieve case
  • Log receipt of self-evident follow-up as communication in IRT
  • Copy and send source docs to Clinical Ops if clinical SAE
  • Check initial source doc completeness
  • Initial follow-up if needed & log communication in IRT
  • Perform duplicate searched
  • Identify exact duplicate doc and archive
  • Perform initial data entry in IRT
  • Determine if AE/Non-AE
  • Identify Non-AE follow-up needs and generate letters and attachments
  • Update Non-AE items as required
  • Identify PQ complaints and notify Quality
  • Attach any provided electronic documents to case in IRT
  • Execute exchange of information (e.g. contractual partners) 
Internal Global Safety Department Development
  • Retrieve physical report charts as required from off-site vendor
  • Demonstrate knowledge of and compliance with established document management processes, guides, policies, and SOPs.
  • Participate in the mentoring and training of new staff 
Contact
Sunny Rajput
Direct: (732) 272 0302 | Email: Sunny.R@sunrisesys.com
Or
Sourabh Agrawal | Lead - Talent Acquisition
Direct: (732) 272 0301| Email: sourabh@sunrisesys.com