Patient Safety Associate (m/w/d).

Job ID: 11673

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Medical Affairs
Type of employment
Project Consulting

To support the Patient Safety team in their daily activities including preparation (from technical perspective) of documents for further processing, review and expediting. Ensure technical compliance of documents with technical guidelines
To support management of Patient Safety operational processes at Country Organization in ensuring compliance with Novartis global/local procedures, national and international regulations/ standards/guidelines for pharmacovigilance of group marketed and investigational products.

  • Prepares the respective submission documents to Health Authorities
  • Supervision of proper flow of confirmations of receipt of documentation sent to the Health Authorities
  • Preparation and everyday distribution of respective Patient Safety (PS) document
  • Participation in the verification process of data correctness in the global safety database
  • Verification of correctness and compliance of documentation sent to Patient Safety Department
  • Preparation of the Patient Safety training materials 
  • Verification and update of respective PS archiving system
  • Manage collection, processing, documentation, reporting and follow-up of all adverse events reports for all group products from clinical trials, non-interventional studies, Patient Oriented Programs, literature, Spontaneous Reports, etc.
  • Record and track receipts, submissions and distributions of SAEs and SRs
  • Manage reporting/submission/distribution of safety reports/updates/information to Local Health Authorities and/or clinical operations
  • Interact and exchange relevant safety information with LHA, PS associates, other functional groups and third party contractor
  • Support in developing, updating and implementing local procedures to ensure compliance with PS global procedures and national requirements
  • Perform reconciliation with other departments for potential AEs resulting from medical inquiries, quality related complaints and other sources
  • Prepare and submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to LHA, development and implementation of corrective action(s) as needed.
  • PSUR-coordinator: prepare local acknowledgement and ensure local filing of concerned documents
  • DSUR-coordinator: ensure timely submission of development safety update reports (DSUR) for investigational medicinal products to competent Local Health Authorities
  • Perform tracking of necessary DSUR submission according DSUR-scheduler/tracker of CMO&PS Global
  • Ensure implementation of ISRM-principles as applicable and in cooperation with Patient Safety Group Head
  • Perform or initiate training compliance analysis upon request by Patient Safety Group Head
  • Experience on similar position in drug safety or drug registration or clinical research department would be an additional asset
  • Proven ability to work in cross-functional teams
  • Computer skills (e.g. Excel, Word, Power Point) and ability to learn new systems quickly
  • Fluent in English & German