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
As a Senior Drug Safety Associate you handle non-serious, serious adverse events and training. You 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 – Argus, based on individual case histories, correspondence with affiliates/sites and other departments in headquarters (HQ) and various administrative assignments.
• You 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. You 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. You should work within strict timelines.
• You ensure that all tasks are performed in compliance in accordance to GXP requirements, maintain a network of safety contacts within Global Safety (GS) and affiliates. Communicating with the SO-DK and affiliates to query and/or clarify the details related to the safety data. You participate in projects in Global Safety or in other parts of the organisation which impacts processes in Global Safety. You liaise with affiliates and partners for local literature and compliance. Liaise with Safety Reporting and IT in all aspects of data retrieval and custom reporting. Participate in inspections and audits when required.
• You assist with related administrative and procedural activities as required or requested. Independent decisions making regarding evaluating the submission of adverse event reports. Ensure compliance with the training plan provided for the role. You act as a buddy for colleagues and provide trainings as required. Contribute to process improvements.
Candidate Profile
• Extensive knowledge of medicinal terminology and clinical pharmacology as well as knowledge of patient treatment, diagnostic investigations and pathology.
• Solid knowledge of pharmacovigilance principles and international regulatory requirements regarding drug safety
• Solid experience with IT, including MS Office (Word, Excel, Outlook, Powerpoint) and data entry
• Speaks and writes English at a professional level
• Solid Novo Nordisk organizational or pharmaceutical company understanding
• Basic knowledge of Novo Nordisk products, incl. mechanism of action, safety profile, patient population, etc
• Good knowledge of GXP requirements
• Knowledge of Pharmacovigilance principles and international regulatory requirements regarding drug safety
• Smart, analytical, time manager, effective communicator
Additional Information
Location : Bangalore, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Clinical Development and Medical
End Date : 31 October 2021
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