Sr. Clinical Safety Scientist

Welcome to Novartis - the company that considers its employees to be its greatest asset. Good Business. Great Opportunities. How do you spend your day? Are you passionate about what you do? At Novartis, our focus is clear, our purpose defined. We're part of a team that's making a difference in the quality of people's lives.Think What's Possible.Performs evaluation of adverse event reports and prepares safety case, periodic safety reports, and patient safety narratives for assigned marketed products in order to fulfill all FDA and global regulatory requirements and medical/ethical obligations. Participates in Clinical Trial meetings with CRD and USCDMA, reviews protocols and assures all safety related responsibilities are established at the start of a new trial. Reviews individual case reports sent from the investigator sites, and assures all are sent to central processing to meet FDA and global regulatory requirements and medical/ethical obligations.Evaluates, codes, routes, and integrates adverse events into the safety documents and expedites cases as required to the FDA for assigned products.Carries out quality control case procedures to meet and exceed global standards for data integrity and regulatory compliance.Works with minimal supervision to assist the Group Head in coordinating interdependent activities involving the clinical teams in Integrated Medical safety and other line units. 1. Performs medical and regulatory evaluations of adverse event reports (spontaneous reports, post marketing surveillance reports and serious adverse events [SAEs]) from clinical trials.2. Interacts with external and internal reporting professionals to ensure case information is adequate and accurate.3. Codes adverse event terminology and other medical information in accordance with standardized dictionaries. Assesses events against the local package insert for regulatory status and for local/international expediting criteria.4. Writes medical case narratives for all US spontaneous and post marketing adverse event reports.5. Processes adverse event reports within legally-specified regulatory timeframes. Conducts data entry as needed.6. Ensures accurate triage of adverse event reports from international sources for expediting purposes.7. Working with the Medical Function, drafts narratives and organizes data for FDA periodic reports.8. Receives requests for database searches, works with safety data management and the medical function to assure the line unit receives the information it requires.9. Interacts with the with special interdisciplinary working teams in all drug safety matters for assigned products (e.g. Biostatistics, Clinical Research, Marketing.10. Assists Group Head in providing guidance, advice and training to junior staff members and to colleagues in other Country Sector Organizations.QualificationsMinimum: Degree in pharmacy or nursing.3+ years of experience as Clinical Safety Scientist [or similar experience] with comprehensive understanding of FDA safety reporting regulations.Skills: computer applications, interpersonal communications, negotiation, problem solving, capacity workload planning.Preferred: Advanced degree in pharmacy or nursing. Novartis is committed to embracing and leveraging diverse backgrounds. Novartis is an equal opportunity employer M/F/D/V.To apply for this position, Click HereTo learn about other Novartis opportunities, Click Here Link to Novartis Pharmaceuticals opportunities Send this Job to a Friend EEO Novartis is committed to embracing and leveraging diverse backgrounds. Novartis is an equal opportunity employer M/F/D/V.