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Novartis
12d ago

Global Program Safety Lead(m/w/x)

Basel
Full-timeWith Home OfficeSenior

Description

You will drive patient safety by leading medical strategies and managing safety data throughout the product life cycle, ensuring clinical programs meet the highest regulatory standards.

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Requirements

  • •PhD, PharmD, or equivalent graduate degree
  • •Three years clinical postdoctoral experience
  • •Five years pharmaceutical drug development experience
  • •Experience in clinical trial methodology
  • •Expertise in clinical safety assessments
  • •Experience with issue management
  • •Experience leading cross-functional multicultural teams
  • •Fluent English language skills
  • •Additional languages as an advantage
  • •Neuroscience experience

Education

Master's degree
OR
Doctoral / PhD

Tasks

  • •Provide expert safety input for clinical development programs
  • •Participate in global program and clinical trial teams
  • •Lead the Safety Management Team
  • •Manage safety issues throughout the product life cycle
  • •Develop and own product safety strategies
  • •Produce medical safety deliverables
  • •Maintain safety information in Core Data Sheets
  • •Address safety issues across all product indications
  • •Oversee signal detection and safety data monitoring
  • •Evaluate and manage safety information from all sources
  • •Prepare safety strategies for health authority responses
  • •Respond to regulatory and healthcare professional inquiries
  • •Lead the development of departmental goals
  • •Develop competencies across the medical safety function

Languages

English – Business Fluent

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