Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy.
Post : Senior Drug Safety Associate
Job Description
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.
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.
Candidate Profile
• Graduation and / or post-graduation in life sciences.
• 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.
Additional Information
Qualification : Graduation and/or post-graduation in life sciences
Location : Bangalore, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Reg Affairs & Safety Pharmacovigilance
End Date : 24th January, 2024
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