Drug Safety Physician

Role & Responsibilities
• Provide medical review, analysis, and guidance during the case handling and reporting cycle of Individual Case Safety Reports (ICSRs) and ADR reports for investigational and marketed products
• Conduct detailed ICSR Medical Review to assess causality, seriousness, and completeness, ensuring compliance with regulatory requirements
• Write safety sections of Aggregate Reports such as PSURs, CASRs, and PADERs, including benefit-risk assessments
• Guide Drug Safety Associates on medical aspects of drug safety, including case assessments and aggregate analysis
• Analyze ADRs during ongoing surveillance and signal detection
• Participate in Safety Review Meetings and client discussions to provide medical insights and recommendations
• Maintain personal readiness for internal audits or regulatory inspections

Qualification
• MBBS, MD in Pharmacology or equivalent

Experience
• Clinical research or pharmacovigilance experience
• Strong understanding of ICSR processes and global safety regulations

Skills
• Analytical and problem-solving skills
• Excellent verbal/written communication skills
• Strong presentation skills
• Client-focused approach to work
• Excellent organizational and prioritization skills

About the Company
• Vizen Life Sciences Pvt Ltd is a leading company specializing in drug safety and pharmacovigilance, offering medical expertise to ensure regulatory compliance and the safety of investigational and marketed pharmaceutical products.