Hybrid Medical Safety Lead – CRM

Posted 8 minutes ago

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About the role

  • Medical Safety Lead in Cardio Renal Metabolic team evaluating patient safety and collaborating with global teams. Driving safety strategies and supporting regulatory documentation processes.

Responsibilities

  • Monitor clinical safety data, literature, and case reports to identify potential safety signals
  • Conduct medical assessments for individual cases, including follow-ups and quality defect evaluations
  • Perform signal detection and evaluation using aggregate and single-case data
  • Contribute to regulatory responses and prepare safety data for health authority reviews
  • Support safety input for core data sheets and related regulatory documentation
  • Collaborate with cross-functional teams on clinical safety deliverables and study documentation

Requirements

  • Master of Science / PharmD / PhD in a relevant field
  • Fluent in spoken and written English; additional language skills are a plus
  • Minimum 4 years of experience in drug development, including 2 years in patient safety
  • Strong knowledge of clinical trial methodology, regulatory requirements, and scientific analysis
  • Proven ability to interpret and present safety data clearly and effectively
  • Experience contributing to clinical safety assessments and regulatory safety reports

Benefits

  • Hybrid working model
  • Opportunity to collaborate with global teams

Job title

Medical Safety Lead – CRM

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Postgraduate Degree

Location requirements

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