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Job Detail

Sr. Medical Safety Operations Associate

Experience Level

1 Year(s)


Piscataway, NJ and Other

Posted Date


Job Requirements

Req. Sr. Medical Safety Operations Associate to perform internal activities and oversee of outsourced activities for ICSR processing and reporting in compliance and quality according to company procedures and FDA requirements; Collect, document, and process adverse event (AE) and serious adverse event (SAE) reports in accordance with company Standard Operating Procedures (SOPs); Prepare clinical narrative summaries  for safety reports; Help to monitor the QC workload to ensure compliance with business partner and regulatory requirements; Ensure timely reporting of safety reports to regulatory agencies, and license partners; Liaising with assigned clinical reviewer to ensure that appropriate review and assessment is provided for ICSRs; Extract safety data and production from MS systems for internal partners and regulatory submissions; Support regulatory agency interactions, inspections and audits. Req. at least a Master’s degree in Analytical Chemistry or related with min. 1 yr. exp. in Pharma industry with  ARGUS, ARISg and IRT safety systems; Travel/reloc to var unantic US locs as req. Mail resume to HRA, MTSS, Inc. 4500 New Brunswick Ave, Ste 102, Piscataway, NJ 08854. MTSS is an EOE.

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