Novartis Safety Labelling Specialist Recruitment - Apply Online

Novartis Safety Labelling Specialist Recruitment – Apply Online

Prepares and implements regulatory maintenance activities and second-wave submissions to achieve targets and business objectives in accordance with the submission plan to avoid stock-outs and delayed launches. Ensures that the preparation of variations follows established processes and timelines. Acts as a strong business partner and project team member for maintenance/compliance matters. Builds a strong interface between the local functions (NTO/ESO/QA) as well as all Sandoz development/maintenance centers to ensure continuous compliance with legal, scientific (technological), ethical and administrative requirements.

Job Title: Safety Labelling Specialist

Job Id: 335500BR

Eligibility Criteria:

• Scientific academic degree, preferably in natural science (chemistry, pharmacy, biology or equivalent) – Masters or Bachelors.

• Good written and spoken English. The local language is an advantage

• At least 3-4 years of relevant experience in the Regulatory/Pharmacovigilance domain with exposure of working in a global organization in generics is preferred.

• Experience in managing databases; creating and maintaining SharePoint; with added skills in Excel, is preferred

• Exposure towards project management is a plus

• Well-structured, result-oriented, highly self-committed, resilient, flexible, team player

• High operational excellence orientation

Your Responsibilities:

Your responsibilities include but not are limited to:

• Update

core texts SmPCs/PLs/Labelling for EU registration procedures MRP/DCP/CP in English for variations and renewals. Coordinate translations for CPs.

•Ensure in-time hand-over of variation package or response documents to submission teams.
Interact with country organizations to ensure timely submission of labeling changes.

•Review and comment on internal or external guidelines and regulations on regulatory, safety and legal topics.Support to Global Labelling Managers on CDS compilation, safety label update evaluation and authoring of documents.

•Ensures patient safety through timely and adequate QC reviews for all CDS updates/periodic regular reviews/first version and CDS re-installation of the core safety information of marketed products.

•Checks signals in the signal management tracking system (cdsDB), including reference product information and regulatory authority communication for review of CDS and related Expert Statements.

•Screen and maintain databases and SharePoint sites as defined within the Global Labelling Team. Supports Compliance Managers in SOP management, PSMF annex preparation, deviations, Audits/Inspections and oversees training matrix.

•Coordinate labeling projects or specific safety tasks as assigned.As needed, mentor new or less experienced team members on regulatory submissions or safety label update evaluation. Technical and administrative support to Global Labelling Managers and Head of Global Labelling.

Apply Online

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