Safety Operations Bangalore is part of Global Safety who has the global responsibility for surveillance of the Safety and Quality of Novo Nordisk clinical development and marketed products. Safety Operations Bangalore is responsible for global handling and reporting of adverse event reports.
Requisition ID – 44014BR
Title – Drug Safety Associate
As a Drug Safety Associate you will be part of a young and dynamic team currently consisting of 58 dedicated employees.
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, on the basis of individual case histories, correspondence with affiliates/sites and other departments in headquarters (HQ) and various administrative assignments.
- 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.
- 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
- To be responsible for Periodic Safety Update Report (PSUR) clean up and other case clean-up activities.
- 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.
- Participate in projects in Global Safety or in other parts of the organisation with impact in Global Safety processes.
- 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.
- 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.
- Act as a buddy for colleagues and provide trainings as required
We also expect you to take an active part in the continuous development of the growing department.
Typical knowledge and specific experience
- Good communication skills (written and oral), with English correspondence.
- Basic working knowledge of MS Windows applications including MS Office tools.
- Basic knowledge of Pharmacovigilance and medicinal terminologies and Clinical Pharmacology.
- Basic knowledge of Pharmacovigilance principles and international regulatory requirements regarding drug safety.
- Basic Novo Nordisk organizational or pharmaceutical company understanding.
- Basic knowledge of Novo Nordisk products, incl. mechanism of action, safety profile, patient population, etc
- Self-motivated and proactive.
- Quick learning and analytical skills.
- Ability to take up initiatives.
- Team oriented personality with high degree of flexibility.
- Ability to capture attention and motivate a team around discussion.
- Ability to work independently and within strict timelines.
- Attention to detail and quality.
- Willingness to occasionally work at unusual times.
- Strive for continuous improvement.