Patient Safety Specialist
2 weeks ago
Patient Safety Specialist:
Singapore
About the role
Internal Role Title:
Patient Safety Specialist
Location:
Singapore #LI-Hybrid
About the Role:
This role is to support management of Patient Safety operational processes at Country Organization ensuring compliance with Novartis global and local procedures, national and international regulations/ standards/ guidelines for vigilance of both marketed and investigational products (incl. drugs, food supplements and medical devices) from Novartis Group.
Key Responsibilities:
- Manage the collection, processing, documentation, reporting and followup of all adverse event reports for all Novartis products from Clinical Trials, Noninterventional Studies, Patient Oriented Program (POPs), Literature, Spontaneous Reports, and any other source of information.
- Transcribe, translate, and enter data from source documents into safety systems accurately and consistently with focus quality and on timeliness. When case processing activities are externalized, liaise with the respective External Service Providers to ensure Novartis Procedures' compliance.
- Manage reporting/submission/distribution of safety reports/updates/information (e.g., SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities (LHA) and/or clinical operations in cooperation with other Country Organization Departments.
- Develop, update, and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
- Interact and collaborate with other departments (such as Medical Affairs, Marketing, Patient Engagement, etc.) to ensure that any projects/ initiatives that potentially involve safety data collection (POPs, DEAs, SM/SML, etc.) follow the Novartis vigilance requirements.
- Management and distribution of vigilance clauses to other departments (such as Legal, Procurement, etc.) to be included in local agreements if necessary
- Advice the owners of local contracts/ agreements with impact in the vigilance system, about the vigilance provisions to be included, as required per Novartis procedures and/or applicable regulations.
- Perform reconciliation with other departments (e.g., Medical Information, Quality Assurance, and Thirdparty contractors, as applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources.
Commitment to Diversity & Inclusion:
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
Role Requirements
Essential Requirements
- Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist), life science degree or equivalent training and experience.
- Knowledge of national and international regulations for pharmacovigilance
- Knowledge of pharmacological and medical terminology
- Good communication and interpersonal skills
- Quality and results oriented
Division
Development
Business Unit
Patient Safety & Pharmacovigilance
Work Location
Singapore
Company/Legal Entity
NOV ASIA PAC PHARMA
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
Yes
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