Novartis Drug Safety Associate Position – Apply Now
Senior Drug Safety Associate
Category: Reg Affairs & Safety Pharmacovigilance
Location: Bangalore, Karnataka, IN
Department: Global Safety GBS (GS – GBS).
Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we might have the right position for you. Apply now and join a growing team, working in an international environment.
The Position
A Senior Drug Safety Associate will perform an initial evaluation of reported adverse events (serious and non-serious) from all sources. The role involves case entry and verification of reported non-serious and serious adverse events; entering 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 narratives comprise 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 affiliates. Perform weekly
literature surveillance-related activities. Ability to work within strict timelines.Qualifications
- 4+ years of relevant experience and/or graduation and/or post-graduation in life sciences is required.
- Sound knowledge of pharmacovigilance is expected.
- Knowledge of medical terminologies and clinical pharmacology.
- Good understanding of the internal and external pharmacovigilance setting and requirements.
- Proficiency with 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, including mechanism of action, safety profile, and patient population.
- Good knowledge of GXP requirements.
About the Department
Global Safety Global Business Service (GS-GBS) was established 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 coordination, and literature surveillance activities, including medical literature monitoring.
