Drug Safety Associate

hace 1 día


Ciudad de México, Ciudad de México Novo Nordisk A tiempo completo

About the Role

We are seeking a highly skilled Drug Safety Associate to join our team at Novo Nordisk in Mexico City. As a Drug Safety Associate, you will play a critical role in ensuring the safety of our products and maintaining high-quality standards.

Key Responsibilities

  • Perform initial evaluation, case entry, and verification of reported adverse events (serious and non-serious) from all sources into the Novo Nordisk safety database, Argus.
  • Ensure accurate coding of events using MedDRA for both serious and non-serious cases.
  • Evaluate causality, seriousness, and listedness for all cases, ensuring correct case narratives.
  • Assess the need for follow-up information, issuing follow-up requests and posting queries in EDC or to affiliates.
  • Conduct weekly literature surveillance-related activities.

Requirements

  • A Bachelor's degree is required. An educational background as a B. Pharm / B.D.S / M. Pharm / Life Sciences.
  • Freshers (0) to a minimum of four (4) years of experience in Pharmacovigilance / Contract research organisations (CROs).
  • Knowledge of Pharmacovigilance principles and international regulatory requirements regarding drug safety.
  • Advanced English proficiency.

About the Department

You will be part of the GBS team in Mexico City, where we define and specify activities, processes, and standards to fulfil the quality requirements for a service or manufactured material, component, or product. 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. Our team is dynamic and committed to ensuring compliance and driving improvements.

Working at Novo Nordisk

At Novo Nordisk, we strive 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. Novo Nordisk relies on the joint potential and collaboration of its 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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