Novartis Jobs For Biology – Specialist, Safety Labelling Vacancy
Novartis Jobs For Biology – Specialist, Safety Labelling Vacancy. Biology candidates apply online for a Specialist, Safety Labelling (MRC) position that is available at Novartis. Novartis is hiring candidates, as per the details below in their Product Dev SZ area:
Job Title: Specialist, Safety Labelling (MRC)
Job ID: 315652BR
Location: Hyderabad, AP
Division: SANDOZ
Business Unit: Product Dev SZ
Employment Type: Full-time
Your Responsibilities For Novartis Jobs:
Your responsibilities include but not are limited to:
- Prep work as well as maintenance of CDS/RSI and also core English SmPCs/PILs/labels for new submissions, variations as well as renewals.
- Signal Detection & Evaluation: perform external signal detection by monitoring HA websites and/or the reference product label and also enter identified signals into the CDS & SD database.
- Evaluation of signals from various sources as well as their impact on patient safety and decide on actions to update labels.
- Organization of translations, if required as well as readability testing of package leaflets. Maintenance of core SmPCs/PILs/labels based upon CMC or administrative changes
- Liaise with Managers to define submission strategy for EU and interact with HAs as required.
- Ensure in-time hand-over of variation package or response documents to submission teams.
- Support in preparation and also maintenance of SOPs/WIs/guidelines, compliance/performance reporting and also oversight. Support labelling projects, audit and inspections, as well as various other specific tasks as assigned.
- Review of labelling documents as well as guarantees that the content adheres to the applicable regulatory requirements as well as standards.
Minimum requirements
What You’ll bring to the role:
- Scientific academic degree, ideally in natural science (biology or equivalent).
- Project management skills.
- Well-structured, result-oriented, highly self-committed, resilient, flexible, team player.
- Ability to communicate and also provide required inputs to stakeholders.
- Experience in managing databases; maintaining SharePoint; with added skills in Excel, is preferred.
- A minimum of 4 years of relevant experience in the domain of regulatory with exposure to working in an international organization in generics is preferred. Fresh campus grads with high learning agility can be taken into consideration.
- Excellent communication abilities in English needed.
APPLY ONLINE
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