Safety Director

About This Role

This hybrid role combines responsibilities for both medical and safety departments. It involves the medical review of individual case safety reports, assessing the relationship between investigational agents and reported events, and ensuring the medical coherence of safety narratives. The role also supports medical monitoring services for ongoing studies and database locks.

Responsibilities

• Oversee medical review of key clinical documents, individual case safety reports, and medical or safety-related regulatory documents
• Oversee and be responsible for medical monitoring services on assigned projects
• Provide support and input into the planning, design, preparation, initiation, and execution of study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practice
• May participate in the evaluation and selection of investigators and study sites as well as analysis of medical activities
• Ensure delivery of medical/clinical direction to investigative sites per contract deliverables
• Prepare medical and safety plans for clinical trials/services
• Review and analyze safety and efficacy trends
• Build up, maintain, and develop internal therapeutic training in assigned studies
• Assist with RFP/RFI completion and attend sales meetings as requested by Business Development
• Oversee collection, review, guidance and manage overall safety case processing as dictated by client contracts
• Oversee reviews and direct medical and safety sections of regulatory document submissions
• May participate in Investigator meetings Team Meetings, DSMB and Safety Review Meetings
• Contribute to the development of medical-related standard procedures and working activities
• Facilitate collaboration and communication with medical/scientific personnel and ensure that the most current research information is accessible for review
• Contribute to development of Safety Management Plans (SMPs), ensuring they are consistent with company SOPs, global PV regulations and guidance from applicable regulatory agencies, ICH and GCPO
• Perform medical review and assessment of ICSRs including serious adverse events (SAEs), adverse events of special interest (AESIs), overdose, and pregnancy exposure from clinical trials
• Evaluate causality, severity, and expectedness of safety events in accordance with protocol, SMP and regulatory guidelines
• Identify and assess emerging safety signals and trends across clinical study data
• Provide medical input into safety narratives, ensuring that they accurately describe the available data and are medically coherent
• Check that the coding of adverse event terms in the safety database using the MedDRA dictionary has been completed accurately