Summary

Internal Role Title: Senior Patient Safety Specialist

Location: Seoul, Korea #LI-Hybrid

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

About the Role:

The Senior Patient Safety Specialist to support management of Patient Safety operational processes at Country Organization ensuring compliance with Novartis global and local procedures, national and international regulations for vigilance of both marketed and investigational products.
This role is to mentor less experienced Patient Safety associates through Patient Safety processes, systems, and operations. To support the implementation of local projects/ initiatives.

• Manage the collection, processing, documentation, reporting and follow-up of all adverse event reports for all Novartis products.Transcribe, translate, and enter data from source documents into safety systems accurately and consistently with focus quality and on timeliness.
• Manage reporting/submission/distribution of safety reports/updates/information.Develop, update, and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
• Interact and collaborate with other departments. To ensure that any projects/ initiatives involving safety data collection follow the Novartis vigilance requirements. Management and distribution of vigilance clauses to other departments
• Advice the owners of local contracts/ agreements with impact in the vigilance system. Ensure compliance with the commitments disposed in the contracts/ agreements. Ensure the applicable local contracts/ agreements are tracked in the respective Pharmacovigilance Agreement SharePoint. Ensure any significant departure from the standard vigilance templates are communicated and endorsed by the global PS Alliance group.
• Perform reconciliation with other departments for potential AEs resulting from medical inquiries, quality related complaints and other sources. Management and maintenance of all relevant local Patient Safety databases.Ensure that relevant local literature articles are screened as appropriate.
• Prepare and submit KPI reports on compliance in a timely. Develop and update training materials for vigilance and ensure training of Country Organization associates on relevant Patient Safety procedures.Ensure support to the internal audits.
• Support the onboarding of new PS associates and mentor less experienced Patient Safety associates under close collaboration with the CPSH or PSGM. Develop draft local RMP/PSUR aligned with latest global RMP/PSUR and RMP implementation/assessment.

• Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist), life science degree or equivalent training and experience.
• Fluent in both written and spoken English, Fluent in both written and spoken local language
• Knowledge of national and international regulations for pharmacovigilance
• Knowledge of pharmacological and medical terminology. Good communication and interpersonal skills. Quality and results oriented
• Project management skills. Computer skills
• At least 2 years working experience as Patient Safety Specialist