Profile for B3
Wipro Limited
Kolkata
2d ago
source : Shine

WBPO Educational Qualification Catalog - , WBPO Experience Catalog -"Responsible for reporting Safety Reports or Periodic Listings to the regulatory authorities.

Responsible for ensuring compliance with global pharmacovigilance regulatory and safety reporting, according to GVP Module VI and FDA CFR Title 21.

Additionally the following needs to be performed : 1) Follow SOPs in place for CIOMS form preparation, generated from database.

The CIOMs will be forwarded to countries for submission 2) Submit regulatory reporting of aggregate reports and periodic listings, for an estimated amount of 10 global and 50 local units / year 3) Ensure documents are correctly formatted, as per regulatory requirements.

4) Ensure accuracy and completeness of the documents, with regard to dates, tables, narratives, etc. 5) Adhere strictly to quality and timelines compliance.

Roles & Responsibilities :

Responsible for reporting Safety Reports or Periodic Listings to the regulatory authorities. Responsible for ensuring compliance with global pharmacovigilance regulatory and safety reporting, according to GVP Module VI and FDA CFR Title 21.

Additionally the following needs to be performed : 1) Perform testing before initiating the electronic transmission with the Eudravigilance production environment 2) Follow SOPs in place for CIOMS form preparation, generated from database.

The CIOMs will be forwarded to countries for submission 3) Submit regulatory reporting of aggregate reports and periodic listings, for an estimated amount of 10 global and 50 local units / year 4) Ensure the document is correctly formatted, as per regulatory requirements.

5) Ensure accuracy and completeness of the document, with regard to dates, tables, narratives, etc. 6) Adhere strictly to quality and timelines compliance."

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