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
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