Regulatory Safety Expert

2 months ago


Noida, India Vitrana Full time

Regulatory Focus

As a Regulatory Safety Expert at Vitrana, you will leverage your expertise in Oracle Argus functionalities, Argus Safety database, and model to drive compliance and excellence in pharmacovigilance. Key responsibilities include:

  • Developing and maintaining strong knowledge of regulatory standards like 21 CFR Part 11, ICH, and GxP.
  • Collaborating with cross-functional teams to ensure seamless integration of Argus Safety services and profiles configurations.
  • Providing case management expertise, including case intake, processing, and distribution.
  • Contributing to the development of product, study, and license configurations, as well as system configuration.
  • Ensuring strong analytical and interpersonal communication skills to drive business growth and customer satisfaction.

Requirements

• Strong knowledge of Oracle Argus functionalities and Argus Safety database and model.

• Good knowledge of PL/SQL and ability to write queries.

• Knowledge on Argus DB, Schemas, Sessions, and troubleshooting experience.

• Working experience on modules like Argus configuration System and Business, Argus Interchange/ESM, and custom E2b profiles.

• Experience/Knowledge in configuring reports in Argus Aggregate and Periodic reports.



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