3 - 5 years

8 - 13 Lacs

Posted:3 days ago| Platform: Foundit logo

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Work Mode

On-site

Job Type

Full Time

Job Description

  • PSUR and ACO scheduling and submission
  • Review and preparation of PADER/PSUR/PBRER, coordination for their submission as per their applicable dates
  • Handling of request received from central and local regulatory affairs and PV department with respect of timeline.
  • Conduct safety review
  • Conducting risk benefit analysis
  • RMP Related activities

  • Assist in developing RMP and allied activities
  • Coordinate with Global team as well as in-house reg team to ensure RMPs are submitted as per their applicable dates
  • Signal management

  • Conduct or assist in all signal detection activities as assigned
  • Preparation and the maintenance of EURD database and coordination with global team
  • Ensure the maintenance of XEVMPD database and coordination with global team

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