A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: GL Associate/Specialist
Job Description:
The GL Associate/Specialist is responsible for the global labelling of assigned Novartis Pharma products across all BUs and BFs to provide high quality information to prescribers and patients whilst minimizing product liability risks.
The GL Associate/Specialist is responsible to support the GL Managers for CDS, BSS, BPL, PSUR, IPL preparation and support to the GL planning and monitoring of the worldwide implementation of corporate agreed product information changes (Core Data Sheet (CDS) updates and amendments) for Novartis Pharma products in order to achieve international harmonization of Pharmaceutical Product Information.
Major Activities:
1. International Package Leaflet (IPL): Prepare, update/amend International Package Leaflets for all Pharma products in compliance with the Core Data Sheet(includes the coordination of translations, Artworks requests, proof-reading of Artwork, and distribution of leaflets to CPOs)
2. Periodic Safety Update Report (PSUR): Provide global regulatory contribution to PSURs for assigned products, and follow up on potential Core Data Sheet changes considered in PSURs
3. Global Product Information: Support the GLM/AGLM to create and maintain regulatory compliant, competitive and up to date global labelling documents (Core Data Sheet (CDS), Basic Patient Leaflet (BPL), Basic Succinct Statement (BSS)) for assigned products.
4. Expert Labelling Task Forces: Support/coordinate in organising and leading cross functional expert labelling task forces to reach consensus on global labelling matters and prepare supporting documents for CDS changes.
5. Interactions with local DRA worldwide: Interact with DRA CPOs and DRA-EM to ensure timely implementation of global labelling changes in local product information, and ensure international consistency and compliance with the CDS. Guide and support DRA CPOs and DRA-EM for all labelling related HA negotiations
6. CDS query management: Support the GLM/AGLMs to lead cross functional Teams in responding to HAs for CDS queries
7. Basic Patient Leaflet (BPL), Basic Succinct statement (BSS): Support the GLM/AGLM in maintaining regulatory com-pliant, competitive and up to date BPL and BSS based on the Core Data Sheet for selected global Novartis Pharma products.
Candidate Profile:
Education (minimum/desirable): University Degree (preferably masters) in Life Sciences or Pharmacy
Languages: Fluency in English as business language, additional languages advantageous.
Experience/Professional requirement: 1 to 4 years in relevant regulatory affairs functions. Alternatively 2-5 years experience in related areas of the Pharmaceutical Industry or Health Authorities. Excellent project management skills and communication along with a sound medical and scientific understanding are required.
Additional Information:
Experience: 2-5 years
Location: Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Other
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 109009BR
Please note: It is no longer necessary to create an account to apply for a position. Simply search for a position, click on Apply and Upload your CV.
See All Novartis Jobs B.Sc Alerts B.Pharm Alerts Hyderabad Alerts
See All Other Jobs in our Database
.png)
