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Patient Safety Specialist

### **Summary** Monitors and audits the company's drug safety surveillance program for pharmaceuticals, biological products, or medical devices, including intake, assessment, processing, and follow-up of adverse reports. Participates in addressing any legal liability and compliance with government regulations. Ensures accurate receipt, maintenance, and evaluation consistent with product labeling. Reports events or reactions as required by regulatory agencies, including adverse event data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May provide detection and evaluation of safety trends and signals. Supports all clinical trial and post-marketing activities. ### **About the Role** Major Accountabilities \~ Support the 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 the 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-oriented programs (POP), registries, and all spontaneous reports (SR). \~ Transcribe, translate (when necessary), and enter data from all serious adverse events (from clinical trials) and all adverse events (from POPs, PMS, registries, and all SRs) from source documents into safety systems accurately and consistently, emphasizing timeliness and quality. \~ Record and track receipt, dispatch, and distribution of documents such as EFS, SRs, Investigator Notifications, etc., in cooperation with other departments \~ Manage submission/presentation/distribution of safety reports/updates/information to local health authorities and/or clinical operations in cooperation with other Departments. \~ Work with other local/global PV partners to ensure accurate assessment of safety data. \~ Interact and exchange relevant safety information with LHA, PV partners, other functional groups, and external contractors, as appropriate. \~ Survey and monitor global/regional/national pharmacovigilance regulations (as applicable) and provide updates to the global PVO organization. \~ Develop, update, and implement local procedures to ensure compliance with global procedures and national PVO requirements. \~ Manage and maintain all assigned PVO databases, as applicable. \~ Develop and update training materials for pharmacovigilance \~ Ensure support and closure of audits, corrective action plan activities, and Health Authority inspections. \~ Provide timely and relevant information to trial coordinators, CRAs, and other Novartis personnel \~ Distribution of marketing samples (when applicable) Key Performance Indicators Monitors and audits the company's drug safety surveillance program for pharmaceuticals, biological products, or medical devices, including intake, assessment, processing, and follow-up of adverse reports. Participates in addressing any legal liability and compliance with government regulations. Ensures accurate receipt, maintenance, and evaluation consistent with product labeling. Reports events or reactions as required by regulatory agencies, including adverse event data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May provide detection and evaluation of safety trends and signals. Supports all clinical trial and post-marketing activities. Work Experience \~ Management and execution of operations \~ International collaboration \~ Functional breadth Skills \~ Presentation (Documents) \~ Pharmacovigilance \~ Safety science \~ Foundations \~ 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 Regular Shift Work No

GXCH+HM Ramallo, Buenos Aires Province, Argentina

Negotiable Salary