Associate Medical Safety Director, Patient Safety

• Serve as a trusted medical authority on oncology product safety profiles, regulatory requirements, and global pharmacovigilance standards
• Provide expert medical judgment on complex safety issues, escalations, and critical assessments
• Represent the medical safety function in client meetings, regulatory audits, and inspections
• Lead signal detection and management activities with scientific rigor and regulatory compliance
• Oversee signal validation and assessment of emerging safety concerns
• Review and contribute to Signal Evaluation Reports and regulatory responses
• Participate in Safety Management Team meetings and drive data analysis and informed decision-making
• Mentor colleagues in signal detection methodologies and best practices
• Oversee safety deliverables across assigned oncology projects
• Provide quality governance and guidance on medical reviews, case assessments, and aggregate safety reports
• Contribute to PBRERs, PSURs, DSURs, and regulatory submissions
• Support medical monitoring activities, including adverse event review and Data Monitoring Committee participation
• Act as the escalation point for unresolved safety issues

• Significant clinical or pharmacovigilance experience in oncology
• Proven experience in signal detection, evaluation, and management within a regulated environment
• Substantial background in drug safety, risk management, and global regulatory compliance (ICH GCP, GVP)
• Strong medical background with the ability to exercise independent judgment on complex safety issues
• Demonstrated success in audits, regulatory interactions, and cross-functional collaboration
• Advanced clinical expertise with strong analytical and strategic thinking abilities
• Exceptional communication skills – able to present complex scientific concepts to diverse audiences
• Leadership capability, balancing technical responsibilities with people management
• Proficiency with pharmacovigilance systems, data analysis tools, and Microsoft Office
• Business acumen and understanding of financial implications of project decisions
• Adaptability and strong commitment to teamwork in a matrix environment
• Medical Degree: MBBS, MD, or equivalent from an accredited medical school
• Completion of basic clinical training (residency, internship, or equivalent)
• Proven expertise in global safety regulations and compliance standards

• Meaningful projects that directly impact patient safety and drug development