Monitor the clinical safety of projects/products through activities such as literature reviews, individual case evaluations, and signal detection; respond appropriately to safety-related inquiries.Conduct medical assessments for cases as needed, including collecting follow-up information, evaluating product quality defects related to adverse events, reviewing single case listings, and preparing notifications for investigators and ethics committees.Identify safety signals from solicited or unsolicited individual cases.Perform signal detection, monitoring, and evaluation of all safety signals.Provide input for responses to inquiries from regulatory authorities and healthcare professionals regarding safety issues.Prepare safety data for review by health authorities.Contribute to responses for legal inquiries and requests from country organizations involving safety concerns.Offer expert evaluations on the clinical context of adverse event reports, assessing medical conditions and their implications for Novartis products.Collaborate effectively on clinical safety tasks with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology, and other related departments.Provide safety inputs for clinical and regulatory deliverables, including clinical study protocols, clinical study reports, and investigator brochures. Participate in Global Program/Brand Team (GPT/GBT), Global Clinical Team (GCT), and Clinical Trial Team (CTT) meetings as needed, and support licensing activities, regulatory inspections, and project/product recall activities.Minimum Requirements Bachelor of Science in Pharmacy, Nursing, PharmD, PhD in a relevant field, or Medical Degree (MBBS or MD) required; specialization preferred. A medical degree is essential for associates performing medical reviews of single case reports as business needs arise.At least 12 years of experience in drug development within a major pharmaceutical company, including 6 years in patient safety in an operational or medical role (or equivalent experience).Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics, and writing publications.Proven ability to analyze, interpret, discuss, and present safety information effectively, both in writing and orally.Experience in preparing or contributing to clinical safety assessments and regulatory reports involving safety information, and in managing safety issues.#J-18808-Ljbffr