Country Head Novartis Patient Safety

6 months ago

Montréal, Canada Novartis Full time

**Summary**:
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

Division

Development

Business Unit

Pharmaceuticals

Location

Canada

Site

Montreal

Company / Legal Entity

CA04 (FCRS = CA004) NOVARTIS PHARMA CANADA INC.

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.

  • Patient Safety Manager

    5 days ago

    Montréal, Canada Novartis Full time

    **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...

  • Patient Safety Specialist

    1 week ago

    Montréal, Canada Novartis Full time

    **Summary**: Location: Montreal/Toronto, #LI-Hybrid We are currently looking for a skilled and dedicated Patient Safety Specialist to join our team. By joining Novartis, you will have the opportunity to be a part of an engaged and dedicated team that is committed to ensuring the safety of our patients. Additionally, you will collaborate with various...

  • Patient Safety Specialist

    1 month ago

    Montréal, QC, Canada Novartis Full time

    **Summary**: Location: Montreal/Toronto, #LI-Hybrid Novartis, you will have the opportunity to be a part of an engaged and dedicated team that is committed to ensuring the safety of our patients. Additionally, you will collaborate with various functions within the company to meet Novartis objectives and fulfill the requirements set by Health...

  • Patient Organized Programs Governance Lead

    3 weeks ago

    Montréal, QC, Canada Novartis Full time

    **Summary**: Location: Montreal #LI-Hybrid About the role: We are seeking an experienced Patient Organized Program (POP) Governance Lead responsible for the end-to-end Patient Oriented Programs (POP - Patient Support Programs, Market Research Programs and Insight Gathering) process and governance in Canada. This role will work directly with the local POP...

  • Communication and Engagement Lead

    6 months ago

    Montréal, Canada Novartis Full time

    Location: Montreal, #LI-Hybrid About the role: We are looking for innovative, experienced and passionate communicators who want to have an impact and make a difference joining us to reimagining medicine. As a Communication and Engagement Lead you will be responsible for creating and driving strategic integrated projects, collaborating in a dynamic...

  • Lead, Patient Access and Healthcare Systems

    7 months ago

    Montréal, Canada Novartis Full time

    392363BR **Lead, Patient Access and Healthcare Systems Partnerships, Quebec**: Canada **About the role** Location: Province of Québec, #LI-Remote Please note that the associate must live in Quebec for this role. About the role: Our healthcare systems lead for Quebec will support 9 million Quebecers. As a member of the Value Access team in Quebec, you...

  • Patient Support Program

    6 months ago

    Montréal, Canada Novartis Full time

    Location: Montreal, #LI-Hybrid About the role: We are looking for experienced and passionate professionals to help us achieve our ambitious mission to reach twice as many neuroscience patients twice as fast. As a PSP Lead, you will be responsible for managing and implementing patient support structures and systems all while achieving KPIs though...

  • Manager, Patient Access

    6 months ago

    Montréal, Canada Novartis Full time

    394123BR **Manager, Patient Access**: Canada **About the role** Location: Montreal, #LI-Hybrid Temporary 12 months About the role: We are looking for innovative, experienced, and passionate market access professionals who want to have an impact and join us on our mission to reimagine medicine. As a Patient Access Manager, you will be proud to contribute...

  • Lead, Patient Access

    6 months ago

    Montréal, Canada Novartis Full time

    395352BR **Lead, Patient Access**: Canada **About the role** Location: Montreal, #LI-Hybrid About the role: We are looking for innovative, experienced, and passionate market access professionals who want to have an impact and join us on our mission to reimagine medicine. As a Lead, Patient Access, you will be proud to contribute to give timely access to...

  • Spécialiste, Sécurité Des Patients

    1 week ago

    Montréal, Canada Novartis Full time

    **Summary**: Lieu : Montréal/Toronto, #LI-Hybrid Nous sommes actuellement à la recherche d’un spécialiste de la sécurité des patients qualifié et dévoué pour se joindre à notre équipe. En vous joignant à Novartis, vous aurez l’occasion de faire partie d’une équipe engagée et dévouée pour assurer la sécurité de nos patients. De plus,...

  • Clinical Project Manager

    7 months ago

    Montréal, Canada Novartis Full time

    394129BR **Clinical Project Manager - Site & Study Operations(SSO)**: Canada **About the role** Location: Montreal, #LI-Hybrid About the role: We are looking for an innovative, experienced, and agile project manager who wants to have an impact on day-to-day planning, executing, and reporting of Global Drug Development (GDD) studies and make a difference...

  • Patient Support Program Lead

    6 months ago

    Montréal, Canada Novartis Full time

    395163BR **Patient Support Program Lead**: Canada **About the role** Patient Support Program Lead Location: Montreal, #LI-Hybrid About the role: We are looking for experienced and passionate professionals to help us achieve our ambitious mission to reach twice as many patients twice as fast. As a PSP Lead, you will be responsible for managing and...

  • Associate and External Engagement Lead

    6 months ago

    Montréal, Canada Novartis Full time

    395162BR **Associate and External Engagement Lead**: Canada **About the role** Associate and External Engagement Lead - Location: Montreal, #LI-Hybrid - About the role: We are looking for innovative, experienced and passionate communicators who want to have an impact and make a difference joining us to reimagining medicine. As Associate and External...

  • Regulatory Affairs Compliance Associate

    6 months ago

    Montréal, Canada Novartis Full time

    395204BR **Regulatory Affairs Compliance Associate**: Canada **About the role** Location: Montreal, #LI-Hybrid 13 month contract About the role: We are looking for an organized, collaborative and passionate regulatory affairs professional who is driven to help us deliver our innovative treatments to patients. As a compliance lead, you will report directly...

  • Spécialiste, Sécurité Des Patients

    1 month ago

    Montréal, QC, Canada Novartis Full time

    **Summary**: Lieu : Montréal/Toronto, #LI-Hybrid Novartis n'est pas en mesure d'offrir une aide à la relocalisation pour ce poste : veuillez postuler uniquement si ce lieu est accessible pour vous. Nous sommes actuellement à la recherche d’un spécialiste de la sécurité des patients qualifié et dévoué pour se joindre à notre équipe. En vous...

  • Medical Goverance Lead

    6 months ago

    Montréal, Canada Novartis Full time

    393570BR **Medical Goverance Lead - Scientific Affairs**: Canada **About the role** Location: Montreal, #LI-Hybrid About the role: We are looking for innovative, experienced and passionate communicators who want to have an impact and make a difference joining us to reimagining medicine. As a Medical Governance Lead (MGL) you will be responsible for the...

  • Chef, Sécurité Des Patients

    5 days ago

    Montréal, Canada Novartis Full time

    **Summary**: Lieu : Toronto/Montréal, #LI-Hybride Novartis n'est pas en mesure d'offrir d’aide pour la relocalisation de ce poste : veuillez uniquement postuler si l’emplacement est possible pour vous. À propos du poste: Nous sommes à la recherche d'un(e) gestionnaire de la Sécurité des patients (SP) qui soutiendra la Cheffe nationale de la...

  • Chef National, Sécurité Des Patients

    6 months ago

    Montréal, Canada Novartis Full time

    **Summary**: Lieu : Montréal, #LI-Hybride A propos du poste : En collaboration avec la direction mondiale de la sécurité des patients et la direction locale, établir et diriger la stratégie de sécurité des patients (SP) et l'excellence opérationnelle au niveau du pays, en conformité avec les réglementations/normes/directives nationales et...

  • Study Start-up Clinical Research Associate

    4 weeks ago

    Montréal, QC, Canada Novartis Full time

    **Summary**: Location: Montreal, #LI-Remote We are seeking an innovative, experienced, and agile start-up CRA who is driven by accelerating the start-up of globally run clinical trials and who is motivated in making a difference in reimagining medicine. About the role: The Study Start-Up CRA is accountable for site selections as well as study-specific...

  • Medical Science Liaison

    6 months ago

    Montréal, Canada Novartis Full time

    Location: Montreal, #LI-Remote About the role: The Medical Science Liaison (MSL) is a member of a field-based team of scientists who function as an extension of the Medical Affairs organization. MSL have scientific expertise in a specific therapeutic area (TA) - MSLs engage in in-depth medical and scientific product or disease area discussions, and...