Patient Safety Specialist
2 weeks ago
Location:
London, Hybrid working, #LI-Hybrid
About the Role:
We are looking for a Patient Safety Specialist to support the 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 Novar-tis 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, 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 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 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
- 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 Patient Safety Alliance group.
- Ensure that relevant local literature articles are screened as appropriate.
- Prepare and submit Key Performance Indicator 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.
- Ensure support to the internal audits, LHA inspections and implementation of the respective CAPA plan
Commitment to Diversity & Inclusion:
- Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve._
Minimum requirements
Essential Requirements
- Health 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
Why Novartis:
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world.
Be a part of this mission and join us Learn more here:
You'll receive
Commitment to Diversity and Inclusion
Novartis is committed to building an outstanding, inclusive work environment and di-verse teams representative of the patients and communities we serve.
Join our Novartis Network:
Division
Global Drug Development
Business Unit
Patient Safety & Pharmacovigilance
Country
United Kingdom
Work Location
London-West
Company/Legal Entity
Novartis Pharmaceuticals UK Lt
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No
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