Drug Safety Associate

hace 2 meses

Mexico City Novo Nordisk A tiempo completo

The position

is based in Mexico City. Position Description: As a Drug Safety Associate – You will be part of a young and dynamic team responsible to handle Serious and Non-serious adverse events. Responsibilities: Perform initial evaluation of reported adverse events (serious and non-serious) from all sources; Perform case entry and verification of reported non-serious and serious adverse events and enter the reported information in the Novo Nordisk safety database Ensure accurate and consistent coding of all events for serious and non-serious cases entered in the Argus with the use of MedDRA (Medical Dictionary for Regulatory Activities); Evaluate causality, seriousness, and listedness for all cases. Assess the need for follow-up information and issue follow-up requests for all cases and post queries in EDC and/or to affiliate Ensure that all tasks are performed in compliance in accordance with GXP requirements. Facilitate root cause investigations, assess the impact on existing safety processes, recommend mitigating actions, and drive d on corrective/preventive actions Act as a buddy for colleagues and provide training as required. Qualifications: Bachelor’s degree is required. An educational background as aas Pharmaceutical Biologist Chemestry (QFB) and Life Sciences is preferred English and Spanish proficiency (written and spoken) For Jr. Drug Safety Associate: No experience needed / For Drug Safety Associate 2-4 year of experience in Pharmacovigilance / Contract research organizations (CROs). Knowledge of Pharmacovigilance principles and international regulatory requirements regarding drug safety; Knowledge of Novo Nordisk products, including mechanism of action, safety profile, patient population, etc. Good knowledge of GXP requirements. About the department: You will become part of a young, dynamic, high-performing affiliate support team who is passionate about working across geographics to help affiliates to handle safety information. The affiliate support function department is part of Global Safety Bangalore Working at Novo Nordisk: Novo Nordisk is its people. We know that life is anything but linear, and balancing what is important at different stages of our careers is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in 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 more than 55, employees. Together, we go further. Together, we’re life-changing.

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