Senior Physician, Patient Safety

• Provide medical review, analysis, and guidance throughout the adverse event and adverse reaction case handling and reporting lifecycle
• Conduct signal detection, analysis, evaluation, and ongoing safety surveillance
• Provide medical guidance to Patient Safety Associates and pharmacovigilance specialists
• Review and provide medical input for Clinical Study Report narratives
• Review and support PSURs, PBRERs, PADERS, Risk Management Plans, Benefit-Risk Assessments, Safety Evaluation Reports, Clinical Overviews, Clinical Expert Statements, and Investigator Notification Letters
• Maintain knowledge of product safety profiles, labeling documents, client procedures, data handling conventions, and international patient safety regulations
• Support compliance with global regulatory requirements, reporting obligations, and timelines
• Collaborate with project managers, clients, and internal stakeholders to resolve safety-related issues
• Participate in client and cross-functional meetings as a patient safety expert
• Support inspection readiness, audits, process improvements, and operational performance objectives
• Perform medical review of individual case safety reports and assess causality, seriousness, and expectedness
• Review and author aggregate safety reports
• Conduct literature reviews for product safety assessment
• Contribute to pharmacovigilance and risk management activities
• Support safety content development and review for clinical protocols, study reports, Investigator Brochures, and regulatory submissions
• Perform signal management activities, including data analysis, assessment, tracking, presentation, and stakeholder collaboration
• Train and mentor team members and serve as a subject matter expert

• Graduation or Post Graduation in Medicine
• Relevant experience in pharmacovigilance, patient safety, or a related field
• Strong knowledge of international patient safety regulations, including GCP and GVP
• Ability to assess the clinical relevance of medical data and interpret its clinical significance
• Excellent interpersonal, verbal, and written communication skills
• Computer proficiency, experience with web-based applications, and familiarity with Windows operating systems
• Ability to manage multiple priorities while maintaining quality and attention to detail
• Ability to work effectively in a matrix environment and collaborate as part of a team
• Preferred: 2+ years of experience in ICSR Medical review, safety surveillance, signal detection, or signal management activities
• Experience preparing, reviewing, or contributing to aggregate safety reports and regulatory submission documentation
• Experience supporting risk management planning and benefit-risk assessments
• Experience training, mentoring, or serving as a subject matter expert within pharmacovigilance operations
• Experience working with investigational and marketed products in a global regulatory environment

• Remote work arrangement
• Full-time employment