Patient Safety Specialist
hace 5 días
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape
**Major accountabilities**:
- To support management of operational processes in ensuring compliance with Sandoz global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance of Sandoz marketed and investigational products -Manage collection, processing, documentation, reporting and follow-up of all adverse events (AE) reports for all Sandoz products from clinical trials, post-marketing studies (PMS), Patient Oriented Programs (POP), registries and all Spontaneous Reports (SR).
- Transcribe, translate (where required) and enter data of all Serious Adverse Events (from Clinical Trials,) and all adverse events (from POPs, PMS, registries and all SRs) from source documents onto safety systems accurately and consistently with emphasis on timeliness and quality.
- Record and track receipts, submissions and distributions of documents like SAEs, SRs, Investigator Notifications etc in cooperation with other departments -Manage reporting/submission/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 associates to ensure accurate evaluation of safety data.
- Interact and exchange relevant safety information with LHA, PV associates, other functional groups and third party contractor, if applicable.
- Survey and monitor global/ regional/national (as applicable) pharmacovigilance regulations and provide update to global PVO organization.
- Develop, update and implement local procedures to ensure compliance with PVO global procedures and national requirements.
- Management and maintenance all relevant assigned PVO databases, if applicable.
- Develop and update training materials for pharmacovigilance -Ensure support for and close-out of audits, corrective action plan activities and Health Authority inspections.
- Provide timely, relevant information to trial coordinators, CRAs and other Sandoz staff -Distribution of marketing samples (where applicable)
**Key performance indicators**:
- Adherence to Sandoz policy and guidelines -Project and stakeholder feedback -Operational risk mitigation and audit/inspection findings -Quality and timely reporting of KPI and safety reports/updates -Results of audits/inspections
**Minimum Requirements**:
**Work Experience**:
- Functional Breadth.
- Collaborating across boundaries.
- Operations Management and Execution.
**Skills**:
- Databases.
- Employee Training.
- Filing (Documents).
- Pharmacovigilance.
- Reporting.
- Safety Science.
**Languages**:
- English.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more
With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Join us
Commitment To Diversity & Inclusion (hard Coded In Workday)
-
Patient Safety Specialist
hace 5 días
Insurgentes, México Sandoz A tiempo completoSandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!**Major accountabilities**:- To...
-
Patient Safety Specialist
hace 2 semanas
INSURGENTES (Sandoz), México Sandoz A tiempo completoJob Description Summary-Monitors and audits the company's drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against...
-
Patient Safety Alliance Manager
hace 6 días
Insurgentes, México Sandoz A tiempo completoAs a newly listed, independent organization, we have an exciting, once-in-a-career opportunity to set our own path forward. **Your Key Responsibilities**: - Maintain knowledge of current and developing regulations for pharmacovigilance and provide expertise and advice to all concerned Sandoz line units and external partners for Sandoz vigilance agreements,...
-
Patient Safety Manager
hace 2 semanas
Insurgentes, México Sandoz A tiempo completoSandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable biosimilar and generic medicines. As we move forward on this new and ambitious path, unique opportunities will arise, both professionally and personally. Join us—the future is in our hands! Major accountabilities: - End to end...
-
Patient Safety Manager
hace 1 semana
Insurgentes, México Sandoz A tiempo completoMajor Accountabilities~ Gestión de principio a fin de procesos asign. de farmacovigilancia en todas las Divisiones de Novartis.~ Responsable de asegurar el cumplimiento de los requerimientos reglamentarios globales con máxima eficiencia~ Dirigir proyectos de seguridad de pacientes multifunc. asignados~ Elaborar y mantener documentos de procedimientos para...
-
Patient Safety Manager
hace 2 semanas
Insurgentes, México Sandoz A tiempo completoMajor Accountabilities ~ Gestión de principio a fin de procesos asign. de farmacovigilancia en todas las Divisiones de Novartis. ~ Responsable de asegurar el cumplimiento de los requerimientos reglamentarios globales con máxima eficiencia ~ Dirigir proyectos de seguridad de pacientes multifunc. asignados ~ Elaborar y mantener documentos de procedimientos...
-
Hse Specialist
hace 1 semana
Insurgentes, México Novartis A tiempo completo**Summary**: The main responsibility of this role is to lead, develop, implement, and oversee effective Health, Safety Environment (HSE), Novartis Emergency Management (NEM) systems in line with local, regional, and global expectations. This involves technical support for numerous Health, Safety, and Environment (HSE) activities following established...
-
Nps, Senior Performance Excellence Analyst
hace 2 semanas
Insurgentes, México Novartis A tiempo completo**Summary**: One of the most important functions in today’s biopharmaceutical industry is patient services. As ease of accessing HCP prescribed medications has become more difficult, the ability of a company to build, design, implement, and run dynamic end-to-end patient support offerings has become critical to patients successfully starting and staying on...
-
Study Start-up Clinical Research Associate
hace 4 semanas
Insurgentes, México Novartis A tiempo completo**Summary**:- Monitors patient data and study-related information related to clinical study sites and clinical trial participation. Ensures the investigator adheres to research protocols, regulatory requirements and good clinical practices and provides input into data validation plan. Provides timely and accurate monitoring of patient data & study-related...
-
Study Start-up Clinical Research Associate
hace 1 día
Insurgentes, México Novartis A tiempo completo**Summary**: - Monitors patient data and study-related information related to clinical study sites and clinical trial participation. Ensures the investigator adheres to research protocols, regulatory requirements and good clinical practices and provides input into data validation plan. Provides timely and accurate monitoring of patient data & study-related...
