Pharmacovigilance Specialist - Brazil, Brasil - IQVIA

Descrição

The Pharmacovigilance team is aiming to provide expertise to the project applying their knowledge in intake adverse event cases


Your responsibilities will include:
Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
Database entry and determining initial/update status of incoming events.

Coding AE and Products, writing narratives, literature related activities, quality review, assisting with reconciliation, case closure related activities, coordinating translations, as per internal/ project timelines.

Creating, maintaining and tracking cases as applicable to the project plan.

Assess Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to meet requirement as per project.

Liaise with relevant stakeholders to facilitate expedited reporting.
Ensure compliance to all project related processes and activities.
Maintain a thorough understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects
To liaise with client in relation to details on day to day activities as needed.
Homebased position.

Minimal requirements

At least 3 yrs experience in pharmacovigilance or related area.
Advanced experience with Oracle Argus Safety/SQL
In depth knowledge and understanding of applicable Safety Database and any other internal/Client applications.
Knowledge of medical terminology
Fluent language in Japanese and English. (mandatory)
Homebased Position.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.

We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world.

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