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Alkem Laboratories Ltd. logo
ICSR Submission Specialist Alkem Laboratories Ltd.

2.0 - 6.0 years

0 Lacs

maharashtra

On-site

You will be responsible for the following tasks in the role: - Validate the quality and reporting criteria of case reports before submission to ensure accuracy and completeness. - Execute the daily generation and submission of ICSRs to global health authorities (e.g., US FDA, EMA) while strictly adhering to reporting timelines. - Manage and execute manual submissions (e.g., via email) for non-gateway regulatory agencies (e.g., PvPI-CDSCO, TGA). - Maintain and adhere to all Expedited Reporting Rules and accurately manage the Submission Clock to ensure zero regulatory deviations. - Perform daily reconciliation within the safety database to ensure 100% submission compliance and data integrity. ...

Posted 3 weeks ago

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