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Amgen Inc logo
Periodic Report Specialist Amgen Inc

1.0 - 3.0 years

3 - 6 Lacs

Hyderabad

Work from Office

What you will do This position plays a role in the authoring, compilation and peer review of Amgens Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e.g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. In compliance with global regulatory requirements. This role supports the end-to-end writing and documentation process and ensures timelines are met. Key Responsibilities: Compi...

Posted 4 months ago

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