Medical Safety Lead
- London
- Permanent
- Full-time
- 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
- Provide medical input for aggregate safety reports and risk management plans
- Collaborate with cross-functional teams on clinical safety deliverables and study documentation
- Offer expert evaluation on adverse event reports and guide pharmacovigilance operations
- 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
- Medical degree (MBBS or MD) with specialization preferred
- Experience managing clinical safety issues