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386 Sandoz Jobs

Global Labeling Manager (GLM), Safety Label Updates

10-15 years

Warangal, Hyderabad / Secunderabad, Nizamabad

1 vacancy

Global Labeling Manager (GLM), Safety Label Updates

Sandoz

posted 7d ago

Job Description

 
  • Identifies new safety information from defined sources, e.g. health authority webpages, email received at generic mailbox and updates to reference product information.
  • Pre-evaluates detected or otherwise collected information and enters it in the signal management tracking system cdsDB.
  • Performs signal evaluation and assess signals under guidance of Global Labeling Manager.
  • Supports timely creation of CDSs required for assigned products.
  • Prepares and revises working instructions concerning safety label updates.
  • Provides Guidance and has oversight on the tasks assigned to the Associates/Specialists within the Global Labelling Team.
  • Assess and Enable Digital Solutions for safety databases to improve efficiency in screening of safety information across various data sources.
  • Supports Audits/Inspection on Safety Label Screening and SOP/WP authoring as an SME (Subject Matter Expert).
  • Contribute and/or review metrics for Safety Label Screening milestone
What you ll bring to the role: Essential Requirements:
  • Degree in Health Sciences or higher, including medical degree, pharmacy, or nursing
  • Minimum 10+ years in safety labelling requirements
  • Cross Cultural Experience.
  • People Challenges.
  • Functional Breadth.
  • Project Management.
  • Collaborating across boundaries.
Skills:
  • Cross-Functional Teams.
  • Detail Oriented.
  • Labeling Documentation.
  • Labeling Regulations.
  • Operational Excellence.
  • Regulatory Compliance.
  • Safety.

Employment Type: Full Time, Permanent

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