Novo Nordisk Hiring 2022. Novo Nordisk Notification full details below..Interested and eligible candidates can Apply Now.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.
- Post Name: Drug Safety Associate-I
- Qualification: Graduation and/or post-graduation in life sciences.
Job Description: Greeting from Novo Nordisk !!!!
Important Details :
- Location: Bangalore, India
- Post of date:23/11/2022
- Deadline: Apply on or before: 28th November, 2022
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to Face
- Interview Rounds of Interview: HR
Roles and Responsibilities
Department: Global Safety
Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you as “Drug Safety Associate” with us. “Apply Now” At Novo Nordisk, we assure you will experience the best.
About the Department
Global Business Service (GS-GBS) was set up in 2010 as one of the hubs for safety case processing. At GS-GBS, we handle case processing from different sources including spontaneous, literature, solicited and clinical trials. Apart from complete case processing and medical review, GS-GBS is also engaged in safety report submission, training, Event Adjudication activities, quality control of individual case safety reports (ICSR), ARGUS configuration and maintenance, information technology quality assurance, training co-ordination and literature surveillance activities, including medical literature monitoring.
As a Drug safety Associate, an ideal candidate will be responsible for performing initial evaluation of reported adverse events (serious and non-serious) from all the sources. The responsibilities include performing case entry and verification of reported non-serious and serious adverse events; entering the reported information in the Novo Nordisk safety database – Argus, based on individual case histories. Coordinating with affiliates/sites and other departments in headquarters (HQ) is also required in this role.
- 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.
- Perform weekly literature surveillance related activities.
- Maintain a network of safety contacts within Global Safety (GS) and affiliates.
- Graduation and/or post-graduation in life sciences.
- Basic knowledge of Pharmacovigilance is expected.
- Basic Knowledge of medical terminologies and clinical pharmacology.
- Basic understanding of the internal and external Pharmacovigilance setting and requirements.
- Basic working knowledge of MS Windows applications including MS Office tools.
- Good communication skills (written and oral), with English correspondence.
- Basic knowledge of GXP requirements.
- Basic knowledge of Pharmacovigilance principles and international regulatory requirements regarding drug safety.