Medical Safety Director - Enterprise Informatics

Job description

Job Title Medical Safety Director - Enterprise Informatics Job Description: Medical Safety Director, Enterprise Informatics The Enterprise Informatics Business portfolio connects clinical informatics, data management and interoperability to deliver improved clinical insights to health care providers. The Medical Safety Director will pioneer comprehensive safety evaluations and risk management strategies, optimizing product efficacy and ensuring patient safety. By staying at the forefront of safety science and regulatory advancements, you will shape the future of medical innovation and empower our team through insightful training and knowledge sharing. Your role: Ensures patient safety by offering medical expertise in Risk Management, Health Hazard Evaluations (HHE), Risk-Benefit Analyses (RBA), and recall procedures. Provides essential input into safety-related sections of regulatory submissions and pertinent documents, including protocols, Clinical Study Reports (CSR), and Clinical Evaluation Reports (CER). Acts as a medical expert, offering safety insights for New Product Introduction (NPI) projects, clinical studies, and Post-Marketing Surveillance (PMS) Initiatives. Conducts co...