Patient Safety Specialist

2023 will see Sandoz become a standalone organization!

As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, its growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact!

This is one such role!

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• 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 product labeling.
  
• Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports.
  
• May provide trending and safety signal detection and assessment. Supports all clinical trial activity and post marketing.
  
• To support management of operational processes in ensuring compliance with global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance of marketed and investigational products.
  
• Manage collection, processing, documentation, reporting and follow-up of all adverse events (AE) reports for all 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.
  

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