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Estudiante en practica


Bogota, NJ
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Job Details

Perform activities under supervision related to dossier submissions, including HA query responses. Maintain updated data in the systems and databases per internal SOPs and policies. Keep in touch, under supervision, with national and international PGS, Hubs and Headquarter in order to obtain and provide the required support. When required, participate in meetings with Trade Associations.

+ Study the sanitary legislation that governs the registration of drugs and company functioning.

+ Learn about technical-scientific knowledge related to product registration (any product regulated by ANVISA).

+ Learn about legislation related to elaboration of package insert and labeling material.

+ Learn about all the documents that comprise the process and the sanitary documents that enable the company to operate.

+ Obtain a bigger picture of the operational routine of a drug manufacturer company.

+ Learn about the organization and functioning of entities related to the pharmaceutical industry.

+ Learn about how Anvisa works.

+ Elaborate in partnership with Submission Hub, under supervision, and/or help prepare the documents and reports required in the registration and query response dossiers according to the legislation in force.

+ Assist the preparation and updating of texts / final artwork (packaging material and labeling) of products according to the documents received from the Headquarter and ensure compliance with the legislation in force.

+ Follow-up, until submission to ANVISA, the registration and query response dossiers those were prepared.

+ Find information pertaining to product registration in specific databases (ANVISA, i-helps and others).

+ Keep the files related to product registration updated and organized.

+ Participate in trade associations meetings (Sindusfarma), when requested.

+ Fulfill all the internal procedures of the company and observe the confidentiality of the information handled by the department.

+ Update Pfizer`s systems and control spreadsheets, under supervision, related to registration activities.

Perform all trainings required for the position.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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