Patient Safety Specialist

327754BR
Oct 08, 2021
China

Job Description

500+ Ongoing clinical trials;160+ Projects in clinical development;80+ Major submissions planned 2020-
2022. Novartis GDD (Global Drug Development) oversees the development of new medicines
discovered by our researchers and partners. It drives breakthrough innovations to improve and extend
the lives of millions.

Your key responsibilities:
Your responsibilities include, but are not limited to:
Your key responsibilities:
• Manage reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SR,
IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities and/or clin-ical
operations in cooperation with other Country Organization Departments.
• Work with other local/global Patient Safety associates to ensure accurate evaluation of safety data.
Interact and exchange relevant safety information with LHA, Patient Safety associates, other functional
groups and third party contractor, if applicable. Survey and monitor national pharmacovigilance
regulations and provide update to global Pa-tient Safety organization.
• Develop, update and implement local procedures to ensure compliance with Patient Safety global
procedures and national requirements. Input, review and approval of program proposals for language,
content and establishment of necessary controls on collection and reporting of adverse event
information.
• Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance and third
party contractor, if applicable) for potential AEs resulting from medical inquiries, quality related
complaints and other sources.
• Ensure support for and close-out of audits, corrective action plan, investigation and Health Authority
inspections. Ensure training and oversight of staff, as applicable. Manage and maintain efficient Patient
Safety filing and archive system.
• Review of all Phase IV Clinical Trial and NIS protocols safety sections and if a Contract Re-search
Organization (CRO) is conducting the trial, review the contract (SSW), train the CRO associates
responsible from the trial.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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Global Drug Development
CMO & PATIENT SAFETY GDD
China
Beijing
Research & Development
Full Time
Regular
No
327754BR

Patient Safety Specialist

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