Sr. Medical Director - Drug Safety and Pharmacovigilance

Job Description

Legend Biotech is seeking a Sr. Medical Director, Drug Safety & Pharmacovigilance. This role is crucial for providing safety strategy and expertise to clinical development and project teams. The Sr. Medical Director will drive risk management initiatives and ensure program consistency across studies.Role involves:

• Leading pharmacovigilance strategy and activities.
• Conducting signal detection and safety information management.
• Leading Safety Monitoring Team (SMT) meetings.
• Providing medical safety review of data from various sources.
• Providing input into critical documents for products in clinical development.
• Managing Urgent Safety Measures.
• Overseeing aggregate reports and signal evaluation reports.
• Managing internal safety scientist and safety operation team.

Requirements:

• MD or MBBS or MD-PhD or equivalent medical degree.
• 5+ years of pharmaceutical experience in Drug Safety & Pharmacovigilance.
• Strong understanding of pharmacovigilance regulations in the US and EU.
• Experience in supporting drug safety activities in registrational clinical studies.
• Experience as a manager, plan and manage daily activities of team; coaches/mentors/trains team; leads performance management activity (goal setting, performance appraisals, etc.)

Role offers:

• Opportunity to lead and support pharmacovigilance strategy.
• Chance to conduct signal detection activities.
• Involvement in medical safety review and input into critical documents.
• Opportunity to manage and oversee safety teams.