Safety Data Analyst

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Juntos creamos un lugar donde somos felices, exitosos y nos inspiramos mutuamente. Aquí es donde puedes hacer tu mejor trabajo.

Únete a nosotros en la intersección de salvar y sostener vidas-donde tu propósito acelera nuestra misión.

Summary

This position is a member of Global Patient Safety Data Management team. The Safety Data Analyst I is responsible for performing searches in the database and generating complete and accurate reports for internal and external customers, including regulatory authorities.  In addition, the Safety Data Analyst is also responsible for ensuring that information entered and retrieved from the databases is consistent and accurate and is also involved in developing and testing new report formats.

Responsibilities

The responsibilities include, but are not limited to the following:

• Generate complete and accurate periodic reports and ad-hoc reports from the Pharmacovigilance database
• Develop and standardize SQL queries to ensure consistency of reports generated
• Collaborate with the report requestor to assure accurate interpretation of the data request 
• Ensure timely completion and distribution of reports and query requests
• Serve as a data integrity escalation contact for downstream users of Pharmacovigilance data (Safety Writers, Drug Safety Physicians, Risk Management, Epidemiology, etc.)
• Ensure consistent interpretation of system related conventions, specifications, and definitions between IT and GPS functional areas
• Collaborate with Safety Systems Analysts and IT to plan and implement system related improvements regarding queries and report generation.  Support may include planning, testing, piloting.
• Participates in developing new report formats using Business Intelligence Tools
• Take initiative to recognize, prioritize & escalate potential safety/compliance issues
• Identify and troubleshoot root causes of thematic data integrity issues
• Identify potential errors and omitted data found during query and address them for review to the responsible user
• Interface and collaborate within the scope of these responsibilities
  • with relevant counterparts in the regional and country Pharmacovigilance functions to facilitate the global exchange of safety info
  • other functions within Pharmacovigilance in all aspects of data management 
  • with other Baxter groups (e.g. Clinical and Medical Affairs, Quality, Regulatory, IT, Legal, business units, etc.).

Qualifications, education and experience

• Bachelor's degree in computer science, life-science or scientific discipline or equivalent
• Previous experience in performing database searches and creating reports out of a database
• One year of previous experience in Safety Data Management or related area is an advantage
• Understanding of Pharmacovigilance terminology is an advantage
• Good knowledge of MS Excel, solid basis of SQL knowledge
• Previous experience with a Business Intelligence tools (e.g. Business Objects) is an advantage
• Solid understanding of database model, ideally of a Pharmacovigilance database
• experience with ARISg is an advantage
• Technical, analytical and problem solving skills in regards to data and queries
• Strong organizational skills with strong attention to detail
• Excellent written and oral communication skills
• Operates effectively in a team environment
• Ability to work under tight timelines
• Strong organizational skills with attention to detail

Adaptaciones razonables

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