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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