Drug Safety Associate

hace 18 horas


Ciudad de México Novo Nordisk A tiempo completo

Drug Safety Associate - GBS México**Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Ciudad de México, Ciudad de México, MX- Join Novo Nordisk for a life-changing career establishing and developing a world-class Global Business Service Centre in Mexico City.- This will impact millions of people living with a chronic disease like diabetes and obesity. It will also impact your professional and personal development through offering you the unique chance to pioneer and build an agile unit offering vital business support to the Americas. Get to know us better by visiting our website.**The Position**- As a Drug Safety Associate at Novo Nordisk, you will:- 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.**Qualifications**- 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 don’t wait for change. We drive change. We’re a dynamic company in an even more dynamic industry, and 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. Novo Nordisk relies on the joint potential and collaboration of its more than 64,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further.**Contact**- We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.- At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in.- Together, we’re life changing.


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