NOVARTIS HEALTHCARE Recruits Freshers Jobs GL Specialist
Job Posted Date: 2012-08-03
Job Title: GL Specialist
Employement Type: Full Time
Job Category: Fresher
Experience: 0 – 2 Years
Location: Hyderabad
Qualification: B.Pharma/M.Pharma
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Description: Planning & Monitoring activities include but not limited to:
1. Maintenance of the Core Global Labelling(GL) Data Base, responsible for keeping track of all GL core information i.e. product assignments, planned updates and amendments, dates of board meetings etc. Extract monthly reports on key information and provide to GL Managements.
2. Maintenance of Resource Planning Sheets, tracking the activities of the GL Managers. Providing monthly activity sheets to GL Management
3. Maintenance of Global Labelling Website as a central source of Core Data Sheets and planning for GL and the CPOs (Country Pharma Organisations).
4. Preparation, updating and amending of the International Package Leaflets (IPL) for all Pharma products in compliance with the Cora Data Sheet changes, as required for registration dossiers, registration samples and for use in export packs (includes the coordination of translations, proofreading of Artwork, and distribution of leaflets to CPOs),
5. Prepare text comparisons with Document Comparison Tool (DCT) e.g. CDS - NPI (selected sections); NPI-NPI; versions; search for keywords.
6. Collect, monitor and archive National Product Information (NPI) worldwide
7. Enter GL-related Post-Distribution Changes (PDCs) into DRAGON (Global regulatory compliance database)
8. Provide administrative support to GL Manager, e.g. in preparing the Updates of the Basic Patient Leaflets and Basic Succinct Statements, in compliance with internal document standards.
9. Prepare registration status reports, e.g. for the Periodic Safety Reports (PSURs).
10. Collaboration within DRA: GL Managers in HQ Basel, East Hanover, India and local Manager and Other GL associates
Minimum requirements Masters/ Bachelors degree in Pharmacy/ Medicine (e.g. Pharmacy, Biotechnology, Pharmacology, Quality Assurance) or equivalent. Excellent English required (oral and written). Note: Submit Your Resume
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