Patient Safety Manager
9 hours ago
**Summary**:
Location: Montreal/Toronto, #LI-Hybrid
About the role:
We are seeking a Patient Safety (PS) Manager to support the Country Patient Safety Head in the implementation of Patient Safety strategy in Canada. In this role, you will be responsible to manage the Patient Safety operational processes ensuring compliance with Novartis global and local procedures, national and international regulations/ standards/ guidelines for the vigilance of Novartis group approved, marketed and investigational products (incl. drugs, food supplements and medical devices).
This role will work directly with the Patient Safety Specialists, Patient Safety Managers and reports to the Country Patient Safety Head (CPSH).
**About the Role**:
**Key responsibilities**:
- To be the accountable for specific operational vigilance process(es) at the Country Organization.
- To mentor less experienced staff, maintaining a professional network of key contacts and role model Novartis values and behaviors.
- Provide scientific expertise during review of all Phase IV Clinical Trial and NIS protocols safety sections including Research Collaborations and if a Contract Research Organization (CRO) is conducting the trial or study, review safety relevant sections of the contract
- Act as a key partner who provides input, during the process of establishing local programs, comments on proposals for vigilance language, content, and establishment of necessary controls on collection and reporting of adverse event information.
- Ensure local PS-related RMP commitments are executed and properly documented.
- Ensure timely preparation and submission of KPI reports, development and implementation of corrective and preventative actions as needed.
- Support in developing and updating training materials for pharmacovigilance and ensure training on relevant PS procedures for AE reporting, including field force and third-party contractor.
- Set up, update, and implement local procedures to ensure compliance with PS global procedures and national requirements.
- Ensure support for and close-out of audits, corrective action plan, investigation, and Health Authority inspections.
- Act as deputy of the Country Patient Safety Head
**What you’ll bring to the role**:
**Essential**:
- Health Care Sciences Professional, life science degree or equivalent training and experience.
- Min. 4 years’ experience in pharmacovigilance in the pharmaceutical industry and/or clinical research organizations.
- Project management skills
- Effective communication and negotiation (networking) skills across different audiences and organizational levels; ability to bridge between scientific and business experts
- Quality focused and results oriented
**Desirable**:
- Fluent in both written and spoken English and French
- Knowledge in the implementation/use of automation solutions like Power BI, AI to enhance data analysis/processes.
Division
International
Business Unit
Innovative Medicines
Location
Canada
Site
Montreal
Company / Legal Entity
CA04 (FCRS = CA004) NOVARTIS PHARMA CANADA INC.
Alternative Location 1
Toronto, Canada
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No
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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