Hybrid Global Program Safety Lead – CRM

Posted last week

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About the role

  • Provide expert safety input to the clinical development program for assigned projects/products
  • Actively participate in the Global Program Team (GPT), Global Clinical Team (GCT), and Clinical Trial Team (CTT)
  • Lead the Safety Management Team (SMT)
  • Responsible for managing safety issues from the formation of the GPT through Life Cycle Management
  • Own the projects/products safety strategy and lead the production of medical safety deliverables
  • Responsible for initial development and ongoing maintenance of safety information in Core Data Sheet, addressing safety issues in all project/product indications
  • Oversee overall signal detection, monitoring, evaluation, interpretation, and appropriate management of safety information
  • Lead the preparation of the safety strategy for health authority responses and collaborate with other project team members
  • Respond to inquiries from regulatory authorities or healthcare professionals regarding safety issues
  • Contribute to and often lead the development of departmental and functional/business unit goals and objectives
  • Proactively engages in the development of competencies across the Medical Safety Function

Requirements

  • Medical Degree or equivalent is preferred; PhD, PharmD or equivalent graduate level health care professional degree required
  • 3 years clinical experience postdoctoral
  • Minimum 5 years experience in drug development in a major pharmaceutical company (of which 2 years in a global position)
  • Including 2 years in safety at an operational or medical position
  • Experience in clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications
  • Expertise in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information
  • Experience with (safety or others) issue management
  • Experience in leading cross-functional, multicultural teams
  • Languages: Fluent English (both spoken and written) is mandatory.
  • Additional desirable skills: Additional languages are an advantage. CRM experience

Benefits

  • Work with cutting-edge technology
  • Collaborate with experts
  • Drive excellence in patient safety
  • Opportunities for professional development

Job title

Global Program Safety Lead – CRM

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Postgraduate Degree

Location requirements

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