### **Summary** Monitors and oversees the company's drug, biological, or medical device safety surveillance program, including intake, evaluation, processing, and follow-up of adverse event reports. Participates in addressing legal liabilities and compliance with government regulations. Ensures accurate receipt, maintenance, and evaluation regarding product labeling. Reports events or reactions as required by regulatory agencies, including adverse event data from clinical studies, spontaneous or solicited sources, periodic reports, and experience reports. May provide signal detection and assessment for safety trends. Supports all clinical trial and post-marketing activities. ### **About the Role** Major Accountabilities \~ Support managing operational processes to ensure compliance with Novartis global/local procedures and national/international regulations, guidelines, and standards 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 studies, post-marketing studies (PMS), patient-oriented programs (POP), registries, and all spontaneous reports (SR). \~ Accurately and consistently transcribe, translate (where necessary), and enter data from all serious adverse events (from clinical studies) and all adverse events (from POP, PMS, registries, and all SRs) from source documents into safety systems, with emphasis on timeliness and quality. \~ Record and track receipt, submission, and distribution of documents such as SAEs, 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 coordination with other departments. \~ Collaborate with other local/global PV associates to ensure accurate assessment of safety data. \~ Interact and exchange relevant safety information with LHAs, PV associates, other functional groups, and third-party contractors, as applicable. \~ Identify and monitor global/regional/national (ad hoc) pharmacovigilance regulations and provide updates to the global PVO organization. \~ Develop, update, and implement local procedures to ensure compliance with global PVO procedures and national requirements. \~ Manage and maintain all assigned PVO databases, as applicable. \~ Develop and update pharmacovigilance training materials \~ Ensure support and closure of audits, corrective action plan activities, and health authority inspections. \~ Provide timely and relevant information to study coordinators, CROs, and other Novartis personnel \~ Distribution of marketing samples (if applicable) Key Performance Indicators Monitors and oversees the company's drug, biological, or medical device safety surveillance program, including intake, evaluation, processing, and follow-up of adverse event reports. Participates in addressing legal liabilities and compliance with government regulations. Ensures accurate receipt, maintenance, and evaluation regarding product labeling. Reports events or reactions as required by regulatory agencies, including adverse event data from clinical studies, spontaneous or solicited sources, periodic reports, and experience reports. May provide signal detection and assessment for safety trends. Supports all clinical trial and post-marketing activities. Work Experience \~Operations management and execution \~Cross-functional collaboration \~Functional extension Skills \~Filing (documents) \~Pharmacovigilance \~Safety science \~Databases \~Employee training \~Chronology 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 Regular Shift Work No