Global Drug Safety Associate

hace 2 meses


Xico, México Novo Nordisk A tiempo completo

As a Drug Safety Associate at Novo Nordisk, you will be responsible for performing initial evaluations, case entry, and verification of reported adverse events in the Argus safety database. This involves ensuring accurate coding of events using MedDRA and evaluating causality, seriousness, and listedness for all cases. You will also assess the need for follow-up information, issue follow-up requests, and post queries in EDC or to affiliates. In addition, you will conduct weekly literature surveillance-related activities. We are looking for a candidate with a Bachelor's degree in a relevant field, such as life sciences, and experience in Pharmacovigilance or Contract Research Organisations (CROs). Advanced English proficiency is also required.

**Job Responsibilities:**

  • Perform initial evaluations, case entry, and verification of reported adverse events in the Argus safety database.
  • Ensure accurate coding of events using MedDRA.
  • Evaluate causality, seriousness, and listedness for all cases.
  • Assess the need for follow-up information and issue follow-up requests.
  • Post queries in EDC or to affiliates.
  • Conduct weekly literature surveillance-related activities.

**Requirements:**

  • Bachelor's degree in a relevant field, such as life sciences.
  • Experience in Pharmacovigilance or Contract Research Organisations (CROs).
  • Advanced English proficiency.

**About the Department:

We are a dynamic team committed to ensuring compliance and driving improvements. Our activities include auditing, monitoring, and determining the quality of processes or outputs against defined internal or regulatory standards. We are responsible for quality assurance of outsourced and licensed manufacturing of semi-finished and finished drug products, facility and utility compliance, and developing quality assurance strategies.

**Working at Novo Nordisk:**

We are a dynamic company in an even more dynamic industry. We know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it's a collective effort. We rely on the joint potential and collaboration of our employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further.



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