### **Summary** Monitor and audit the company's drug, biological product, or medical device surveillance program, including intake, evaluation, processing, and follow-up of adverse event reports. Participate in addressing any legal liability and compliance with government regulations. Ensure accurate receipt, maintenance, and evaluation regarding product labeling. Report required events or reactions to regulatory agencies, including adverse event data from clinical trials, spontaneous or solicited sources, periodic reports, and experience. May provide detection and assessment of safety trends and signals. Support all clinical trial and post-marketing activities. ### **About the Role** Major Accountabilities \~ Support management of operational processes to ensure compliance with Novartis global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance of marketed and investigational Novartis products \~ Manage collection, processing, documentation, reporting, and follow-up of all adverse event (AE) reports for all Novartis products from clinical trials, post-marketing studies (PMS), patient-focused programs (PFP), registries, and all spontaneous reports (SR). \~ Accurately and systematically transcribe, translate (if needed), and enter data from all serious adverse events (from clinical trials) and all adverse events (from PFP, PMS, registries, and all REPORTS) from source documents into safety systems, emphasizing speed and quality. \~ Record and track receipt, submissions, and distribution of documents such as SUSARs, SRs, investigator notifications, etc., in collaboration with other departments \~ Manage reporting/submission/distribution of safety reports/updates/information to local health authorities and/or clinical operations in collaboration with other departments. \~ Work with other local/global PV associates to ensure accurate assessment of safety data. \~ Interact and exchange relevant safety information with LHA, PV associates, other functional groups, and third-party contractors as applicable. \~ Investigate and monitor global/regional/national (as applicable) pharmacovigilance regulations and provide updates to the global PV organization. \~ Develop, update, and implement local procedures to ensure compliance with global procedures and national PV requirements. \~ Management and maintenance of all relevant PV databases as applicable. \~ Develop and update training materials for pharmacovigilance \~ Provide support and closure for audits, corrective action plan activities, and health authority inspections. \~ Provide timely relevant information to trial coordinators, CRAs, and other Novartis employees \~ Distribution of commercial samples (if applicable) Key Performance Indicators Monitor and audit the company's drug, biological product, or medical device surveillance program, including intake, evaluation, processing, and follow-up of adverse event reports. Participate in addressing any legal liability and compliance with government regulations. Ensure accurate receipt, maintenance, and evaluation regarding product labeling. Report required events or reactions to regulatory agencies, including adverse event data from clinical trials, spontaneous or solicited sources, periodic reports, and experience. May provide detection and assessment of safety trends and signals. Support all clinical trial and post-marketing activities. Work Experience \~ Management and execution of operations \~ Cross-border collaboration \~ Functional scope Skills \~ Document submission \~ Pharmacovigilance \~ Safety science \~ Fundamentals \~ Employee training \~ Reporting Language English **Why Novartis:** Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people\-and\-culture **Join our Novartis Network:** Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network **Benefits and Rewards:** Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits\-rewards Division Development Business Unit Innovative Medicines Location Argentina Site Ramallo (Argentina) Company / Legal Entity AR01 (FCRS \= AR001\) Novartis Argentina S.A. Functional Area Research \& Development Job Type Part time Employment Type CDI Shift Work No