Novo Nordisk Pharmacovigilance Drug Safety Expert I Job Openings at Bangalore Location.
Category: Clinical Development and Medical
Location: Bangalore, Karnataka, IN
- As a Drug Safety Expert unit, you will be the one who set and achieve day-to-day operations with some impact on others within or outside the unit.
- Handling of non-serious and serious adverse events. Training on the process.
- Actively participate in audits and inspections. Ensure cross organizational communication and cooperation; and support implementation of new processes based on increased regulatory requirements and in accordance with GS’s strategic framework. SOP author.
- Typically reports to a Head of the Project
Handling of Non-serious and Serious adverse events:
- 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.
- 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 ness 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.
- Perform weekly literature surveillance related activities.
- Ability to work within strict timelines.
- Ensure that all tasks are performed in compliance in accordance with 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.
- Having extensive knowledge of Novo Nordisk global safety database (Argus) and Global Customer Complaint System (CCGloW).
- Must be owner or involved in the creation and maintenance of standard operating procedure.
- Global Safety processes.
- Assist/provide response to health authority requests.
- Support implementation of new processes and/or requirements based on increased regulatory requirements.
- Ensure cross organizational communication and cooperation with regards to safety information
This position requires you to be highly self-motivated, proactive, organised and have excellent stakeholder management, communication skills. Ensure quality of submissions by complying to procedures and systems.
- Graduation and /or Post Graduation in (life Sciences)
- 7 – 10 years of experience in a similar environment.
- Sound knowledge of Pharmacovigilance is expected.
- Knowledge of medical terminologies and clinical pharmacology.
- Good understanding of the internal and external Pharmacovigilance setting and requirements.
- Sound working knowledge of MS Windows applications including MS Office tools.
- Solid Novo Nordisk organizational or pharmaceutical company understanding.
- Excellent communication skills (written and oral), with English correspondence.
- Good presentation skills
- Solid knowledge of Novo Nordisk products, incl. mechanism of action, safety profile, patient population, etc.
- Well versed with CAPA (Corrective and Preventive Action) process.
- Expert in Case Management Request vertical.
- Good knowledge of GXP requirements.
- Solid knowledge of Pharmacovigilance principles and international regulatory requirements regarding drug safety
Deadline : 29 June 2022
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants