REQ-10006943
Keskiviikko, 5 Kesäkuu 2024
Canada
Yhteenveto
Location: Montreal, #LI-Hybrid
About the role:
In collaboration with the global patient safety and local leadership, establish and drive Patient Safety (PS) strategy and operational excellence at country level, in compliance with the national and international regulations/standards/guidelines and corporate procedures, for all marketed and investigational products - drugs and medical devices - under the responsibility of all Novartis companies and divisions. As CPSH in a large country with high regulatory demands and visibility, head the local PS department and ensure the oversight of the quality management system for the PV system at local level, in collaboration with the Quality Assurance (QA) function.
As a senior member in the country, influence local/global strategies to promote consistency and alignment between global and local PV-related processes and activities to meet local/global regulatory requirements. Supports the global/ regional talent development strategy by coaching and mentoring less experienced PS associates.
About the Role
Major accountabilities:
- Monitors and audits the company’s drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports.
- Participates in the resolution of any legal liability and in complying with government regulations.
- Ensures accurate receipt, maintenance and assessment against product labeling.
- Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May provide trending and safety signal detection and assessment. Supports all clinical trial activity and post marketing.
- Ensure compliance with Novartis global and local procedures, national and international regulatory requirements in the assigned Region/Countries
- Acts as a key Partner for Global and Local Novartis Patient Safety in order to drive safety processes excellence -Drives compliance including coordination and execution of new Novartis and/or regulatory requirements and inspection readiness via Local Novartis Patient Safety teams.
- Provide key leadership skills based on expertise to the country to meet the strategic vision and regulatory requirements necessary
- Key member in the country organization in a local organization that has high commercial and regulatory visibility. Key member of the local leadership team or influencing local leadership team to assure the country is meeting its regulatory obligations to the local health authority.
What you'll bring to the role:
Essential:
- Minimum 7 years’ experience in drug-safety or pharmacovigilance (preferred) and/ or experience in pharmaceutical industry
- Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist) or equivalent education, training and experience
- Clinical Research.
- Clinical Trials.
- Regulatory Compliance.
- Safety Science.
- Team Management and leadership
- Managing Crises.
- Operations Management and Execution.
- Collaborating across boundaries.
- English and French - advanced level
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
Development
Pharmaceuticals
Canada
Montreal
CA04 (FCRS = CA004) NOVARTIS PHARMA CANADA INC.
Research & Development
Full time
Regular
No
