Medical Director

• Lead safety evaluation and benefit-risk assessments for assigned products
• Support pharmacovigilance and risk management activities across clinical development and marketed products
• Contribute to regulatory submissions and health authority interactions
• Prepare and review scientifically sound responses to Health Authority Requests for Information (RFIs)
• Analyze and interpret clinical and safety data to support regulatory and business decisions
• Participate in cross-functional safety governance and product safety discussions
• Provide protocol and regulatory support throughout the development lifecycle
• Escalate significant safety concerns and emerging risks when appropriate

Medical Director, SERM, Clinical Safety, Pharmacovigilance

• Provide medical oversight of clinical trials to ensure SOPs, client directives, GCP and regulatory requirements are followed
• Attend and present at investigator and sponsor meetings
• Provide medical consultation to clients, investigators and project team members
• Support business development activities
• Provide medical review and analysis of serious adverse events, marketed-product ICSR and periodic safety reports
• Manage medical aspects of contracted tasks across the pharmaceutical product life-cycle
• Ensure pharmacovigilance tasks are properly executed and comply with regulations, ICH guidelines, client SOPs and project procedures
• Answer study-related medical questions and maintain communication with associates and clients
• Provide therapeutic and protocol training
• Write or review CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, CTD modules and related deliverables
• Monitor safety variables in clinical studies, including adverse events, laboratory abnormalities, medical-status changes, concomitant medications and unblinding requests
• Discuss medical concerns with principal investigators and clients and make clinical decisions relating to investigational studies
• Review adverse events of special interest, serious adverse events and clinical outcomes reported by study sites
• Perform contracted data review and assess potential safety concerns
• Manage signal detection, review aggregate reports, contribute to label updates and support dossier maintenance and risk management
• Medically review adverse-event and serious-adverse-event data from solicited, spontaneous and literature sources

Medical Director jobs in Brazil

Medical Director, SERM, Clinical Safety, Pharmacovigilance

Senior Medical Director – Endocrinology