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Patient Safety Specialist

### **Summary** Monitors and audits the company's surveillance program for drugs, biologics, or medical devices, including the 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 according to product labeling. Reports events or reactions as required by regulatory authorities, including adverse event data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May enable trend and safety signal detection and assessment. Supports all clinical trial activities and post-marketing activities. ### **About the Role** Major Accountabilities \~ Supporting management of operational processes to ensure compliance with Novartis global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance of marketed and investigational products from Novartis \~ Managing 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 support programs (POP), registries, and all spontaneous reports (SR). \~ Accurately and consistently transcribe, translate (if necessary), and enter data from all serious adverse events (from clinical trials) and all adverse events (from POPs, PMS, registries, and all SRs) into safety systems from source documents, emphasizing timeliness and quality. \~ Recording and tracking evidence, submissions, and distribution of documents such as SAEs, SRs, investigator notifications, etc., in collaboration with other departments \~ Managing the reporting/submission/distribution of safety reports/updates/information to local health authorities and/or clinical operations in coordination with other departments. \~ Collaborating with other local/global PV staff to ensure accurate evaluation of safety data. \~ Interacting and exchanging relevant safety information with LHAs, PV staff, other functional groups, and third parties as appropriate. \~ Gathering and monitoring global/regional/national (where applicable) pharmacovigilance regulations and providing updates to the global PVO organization. \~ Developing, updating, and implementing local procedures to ensure compliance with global PVO procedures and national requirements. \~ Managing and maintaining all relevant assigned PVO databases, where applicable. \~ Developing and updating pharmacovigilance training materials \~ Ensuring support and de-escalation of audits, corrective actions and preventive actions (CAPA), and health authority inspections. \~ Providing timely, relevant information to study coordinators, rating agencies, and other Novartis employees \~ Distribution of marketing samples (if applicable) Key Performance Indicators Monitors and audits the company's surveillance program for drugs, biologics, or medical devices, including the 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 according to product labeling. Reports events or reactions as required by regulatory authorities, including adverse event data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May enable trend and safety signal detection and assessment. Supports all clinical trial activities and post-marketing activities. Work Experience \~Operations Management and execution \~Cross-border collaboration \~Functional breadth Skills \~Filing (documents) \~Pharmacovigilance \~Safety science insights \~Databases \~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