Senior Drug Safety Associate

1 week ago

Bengaluru, Karnataka, India Novo Nordisk AS Full time

Department : Global Safety GBS (GS - GBS).

Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we might have the right position for you. Apply now and join a growing team, working in an international environment.

The Position

A Senior Drug Safety Associate will 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; enter the reported information in the Novo Nordisk safety database based on individual case histories, correspondence with affiliates/sites and other departments in headquarters (HQ) and various administrative assignments. Evaluate causality, seriousness and listedness for all cases. Ensure that case narrative comprises correct and appropriate safety information. Assess the need for follow up information and issue follow up requests for all cases and post queries in EDC and/or to affiliate. Perform weekly literature surveillance related activities. Ability to work within strict timelines.

Qualifications

4+ years of relevant experience /Graduation and/or post-graduation in life sciences is required. Sound knowledge of Pharmacovigilance is expected. Knowledge of medical terminologies and clinical pharmacology. Good understanding of the internal and external Pharmacovigilance setting and requirements. Sound working knowledge of MS Windows applications including MS Office tools. Solid Novo Nordisk organizational or pharmaceutical company understanding. Excellent communication skills (written and oral), with English correspondence. Solid knowledge of Novo Nordisk products, incl. mechanism of action, safety profile, patient population, etc. Good knowledge of GXP requirements.

About the Department

Global Safety Global Business Service (GS-GBS) was set up in 2010 as one of the hubs for safety case processing. We handle case processing and medical review of Individual Case Safety Reports from different sources (spontaneous, literature, solicited and clinical trials). We are additionally engaged in safety surveillance, safety medical writing, safety report submission, training, quality control of ICSRs, Argus configuration and maintenance, information technology quality assurance, training co-ordination and literature surveillance activities, including medical literature monitoring.

Working At Novo Nordisk

At Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions. Our treatments today are benefiting millions of people living with diabetes, obesity, and rare blood and endocrine diseases. From our labs to our factory floors, we are discovering and developing innovative biological medicines and making them accessible to patients throughout the world. Since the company was founded in Denmark more than 100 years ago, we have been translating the unmet medical needs of people living with serious chronic diseases into innovative medicines and delivery. Our focus is on these diseases, which affect hundreds of millions of people and are among the most urgent global health challenges. By combining our innovation and commercial excellence, we draw upon insights from patients and partners to transform bold ideas into life-saving and preventive medicines. Our ambition is to take the lead in each of these areas, driving change with an unfailing belief that it can be done.

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