Novartis MRC Safety Specialist Vacancy – Apply Online
Sandoz, a Novartis company, embraces diversity, equal opportunity, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Job ID 315652BR
Job Title Specialist, Safety Labelling (MRC)
Eligibility
• Scientific academic degree, preferably in natural science (chemistry, pharmacy or equivalent)
• Project management skills
• Well-structured, result-oriented, highly self-committed, resilient, flexible, team player
• Ability to communicate and provide required inputs to stakeholders
• Experience in managing databases; maintaining SharePoint; with added skills in Excel, is preferred
• At least 4 years of relevant experience in the domain of regulatory with an exposure of working in a global organization in generics is preferred. Fresh campus graduates with high learning agility can be considered.
• Excellent communication skills in English required
Job Description
1886! We have more than 130 years of experience treating patients. Sandoz, a division of Novartis, is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide.
Your Responsibilities:
Your responsibilities include but not are limited to:
• Preparation and maintenance of CDS/RSI and core English SmPCs/PILs/labels for new submissions, variations, and renewals.
• Signal Detection & Evaluation: perform external signal detection by monitoring HA websites and/or the reference product label and enter identified signals into the CDS & SD database.
• Evaluation of signals from various sources and their impact on patient safety and decide on actions to update labels.
• Organization of translations, if needed, and readability testing of package leaflets. Maintenance of core SmPCs/PILs/labels based on CMC or administrative changes
• Liaise with Managers to define submission strategy for EU and interact with HAs as needed.
• Ensure in-time hand-over of variation package or response documents to submission teams.
• Support in preparation and maintenance of SOPs/WIs/guidelines, compliance/performance reporting, and oversight. Support labeling projects, audit and inspections, and other specific tasks as assigned.
• Review of labeling documents and ensures that the content complies with the applicable regulatory requirements and guidelines.
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