Life Sciences Drug Safety Associate-I Job at Novo Nordisk, Apply Online
Life Sciences Drug Safety Associate-I Job at Novo Nordisk, Apply Online. Life Sciences Jobs. Life Sciences Drug Safety Associate-I Vacancy. Interested and eligible applicants can check out all of the details on the same below
Drug Safety Associate-I
Category: Clinical Development and Medical
Location: Bangalore, Karnataka, IN
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 the best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you as a “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.The position
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 listed news for all cases.
- Ensure that the 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.
Experience
- 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.
Working At Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, to manufacturing, marketing and sales- we’re all working to move the needle on patient care.
Contact
If you believe you are a match for the above requirements and are willing to take up the role, please apply here with our online application tool.
Deadline
Apply on or before: 28th November 2022
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