tailk- 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 agevolazioni-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 sa…
Director, Medical Safety - Roma, Lazio, Italy
Iqvia
IT
🎯 Intermedio🧭 Healthcare🏢 Sanità🗣️ Italiano
Competenze richieste
risk managementregulatory submissionslabeling
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