Sumar
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
