1 - 4 years

3 - 6 Lacs

Posted:1 day ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

  • Principle Accountabilities
  • Case processing / data entry and related activities in the Argus safety database as per DE conventions within specified timelines.
  • Participate in downloading, triaging, uploading and book-in of regulatory and EMA MLM ICSR reports.
  • Participate in triaging and book-in of literature reports.
  • Triage, Case book-in, data entry archiving.
  • Ensure use of PV-MedDRA for coding adverse reactions
  • Documentation
  • Ensure that pharmacovigilance SOPs, procedures, processes, and guidelines are adhered to communicate with external and internal customers in a timely manner, as per the requirement.
  • Statutory Compliances
  • Maintain an awareness of current legislation associated with the Worldwide Regulatory Pharmacovigilance requirements.
  • Ensures regulatory compliance by providing timely, quality information for aggregate reports and signal review following SOPs and regulations. ",nan

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