Drug Safety Associate

Encontrado en: Talent MX C2 - hace 3 semanas

Mexico City Novo Nordisk AS A tiempo completo

Are you eager to accelerate the development and communication in the drug safety area for Novo Nordisk? Do you want to start your career or do you have experience as Drug safety associate? We are looking for Jr. Drug safety associates and Drug safety associates to join our team in GBS (Global Business Service Centre) Mexico. If you are ready for a new challenge and want to make a difference in the healthcare industry, read on and apply today for a life-changing career.

Drug Safety Associate Starting a career at Novo Nordisk is more than getting a job. It is an opportunity to improve the lives of millions of people living with a serious chronic disease. We are a proud life-science company on a mission to ensure that people living with chronic diseases can live full life. Millions rely on us. It is very important to us that anyone working with us feels empowered as an employee and as a person. We all should have the opportunity to act fast, make decisions, and be agile.

We are looking for potential candidates for the  Jr.Drug Safety Associate  & Drug Safety Associate roles in Global Safety. This positions involves a high level of coordination with colleagues at Global Safety Bangalore and affiliates. 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

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