Responsibilities
• Conduct medical review of clinical trial and post-marketing safety data, including adverse events (AEs), adverse drug reactions (ADRs), coding, causality, expectedness, seriousness assessments, and vantaggi-risk evaluations.
• Provide medical oversight and review of safety documentation, including narratives, aggregate reports, annual and periodic safety reports, risk management plans, regulatory submissions, labeling, protocols, investigator brochures, and case report forms.
• Support safety governance activities, including Data Safety Monitoring Boards, Safety Monitoring Committees, medical information escalations, pharmacovigilance oversight, and 24-hour medical support as required.
• Serve as Global Safety Physician, project lead, or medical safety advisor, ensuring quality, compliance, operational delivery, training, stakeholder communication, and timely completion of deliverables.
• Present safety findings and provide expert medical consultation to clients, internal teams, and cross-functional stakeholders.
• Lead and develop medical safety teams through people management, workload planning, performance management, mentoring, training, resource allocation, and succession planning.
• Oversee financial, operational, and quality performance of assigned projects, ensuring appropriate resourcing and regulatory compliance.
• Contribute to business development activities, including proposals, budgeting, bid defenses, client presentations, strategic planning, and service-line growth initiatives.
• Represent the Medical Safety function internally and externally, maintaining key stakeholder relationships and supporting organizational objectives.
• Drive continuous improvement through awareness of industry, regulatory, and pharmacovigilance developments, and undertake special projects as required.
• Provide global medical safety and pharmacovigilance oversight across clinical development and post-marketing programs.
• Lead medical review of safety data
📌 Director, Medical Safety (Roma)
🏢 Iqvia
📍 Roma