Head Risk Management

hace 2 semanas

Barcelona, España Innovative Medicines A tiempo completo

SummaryResponsible for establishing and maintaining the risk governance framework within PSPV; including identification management of risks within the pharmaco- and medical devices vigilance system PV Quality Management System (QMS) for Novartis group.
It includes escalating risks to senior PSPV; leadership and overseeing the development and implementation of appropriate remediation plans at Corporate level to protect Novartis reputation.About the Role- Drive the strategy and adoption of robust risk management practices across the Vigilance System; oversee that teams are properly implementing the risk management cycle, quality issue management and methodologies and adhere to Novartis Corporate Standards.- Establish and maintain the risk governance framework across PSPV; in partnership with Ethics, Risk Compliance, Quality Assurance and other stakeholders- Lead a team of Vigilance Risk Management Managers, Experts and Associates responsible for PV system risk management and oversight of identified risks, their respective mitigation plans and trending.- Benchmark risk governance standards across the industry, review emerging worldwide regulations, performing global impact assessments, and driving global process changes required to ensure ongoing compliance to global regulatory requirements in managing risks.- Proactively monitor risks for trends and patterns; drive lessons learned and collaborate with stakeholders across Development and at Enterprise level to lead the delivery of sustainable and effective action plans.- Act as Risk Compliance Committee officer, preparing process owners to present vigilance risks and robust mitigation plans to senior PSPV; leadership, and supporting the chair with the conduct of the board.- Lead and support strategic projects related to Risk Management and Governance of the Novartis Vigilance System.- Lead the development and maintenance of respective processes including ownership of relevant PSMF sections and annexes, procedural/guidance documents training.- Monitor compliance of the PSPV; organization to deviation and quality incident handling processes and standards and where deficiencies are identified, develop and implement strategies to address these.- Collaborate with the Compliance, Process Excellence, QPPV Office and other functions to produce metrics and complete trend analyses designed to identify areas of risk with impact on the Vigilance System and/or PSPV; organization.- Collaborate with other Global Line Functions across Novartis group and Third Parties to establish and meet joint accountabilities ,including the non-drug risk management strategy across Development.- Acts as the subject matter expert on vigilance risk management during audits and inspections, lead the preparation of responses to findings in scope of assigned responsibilities and ensure appropriate CAPAs are developed, implemented and effectiveness verified.- Recruit and develop talents and retain high performing associates.
Set-up regular performance evaluations, development and succession planning- Support the Head of Compliance Risk Management to determine OPEX strategy and set OPEX objectives.- Deputize for the Head of Compliance Risk Management and the PSPV; Quality System Owner as neededEducationPharmD, MSc degree in life sciences or equivalent.LanguagesFluency in English.
Knowledge of other languages desirable.Professional requirement- Minimum 7 years of experience in the pharmaceutical industry, particularly pharmacovigilance with advanced knowledge of pharmacovigilance regulations- At least 2 years of leadership /project management experience.- Quality assurance experience of advantage- Ability to lead and deliver cross-functional initiatives in a matrix environment.- Strong organizational and project management skills.- Strong negotiation and ability to operate effectively in an international, matrix environment- A strong communicator with the ability to deal and interact with a wide variety of people at all levels.- Quality focus- Strong analytical/investigative skillsWhy 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?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: #J-18808-Ljbffr

  • Head Risk Management

    hace 3 meses

    Barcelona, España Novartis A tiempo completo

    **Summary**: Responsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco - and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and...

  • Head Risk Management

    hace 1 mes

    Barcelona, España Novartis Farmacéutica A tiempo completo

    Responsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco- and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and implementation of...

  • Head Risk Management

    hace 4 semanas

    Barcelona, España Novartis A tiempo completo

    Responsible for establishing and maintaining the risk governance framework within PSPV including identification management of risks within the pharmaco- and medical devices vigilance system PV Quality Management System (QMS) for Novartis group.It includes escalating risks to senior PSPV leadership and overseeing the development and implementation of...

  • Head Risk Management

    hace 4 semanas

    Barcelona, España Novartis A tiempo completo

    Responsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco- and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and implementation of...

  • Head Risk Management

    hace 1 mes

    Barcelona, España Novartis Farmacéutica A tiempo completo

    Responsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco- and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and implementation of...

  • Head Risk Management

    hace 1 mes

    Barcelona, España Novartis Farmacéutica A tiempo completo

    Responsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco- and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and implementation of...

  • Head Risk Management

    hace 1 mes

    Barcelona, España Novartis Farmacéutica A tiempo completo

    Responsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco- and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and implementation of...

  • Head Risk Management

    hace 4 semanas

    Barcelona, España Novartis A tiempo completo

    Responsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco- and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and implementation of...

  • Head Risk Management

    hace 1 mes

    Barcelona, España Novartis Farmacéutica A tiempo completo

    Responsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco- and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and implementation of...

  • Head Risk Management

    hace 1 mes

    Barcelona, España Novartis Farmacéutica A tiempo completo

    Responsible for establishing and maintaining the risk governance framework within PSPV including identification management of risks within the pharmaco- and medical devices vigilance system PV Quality Management System (QMS) for Novartis group.It includes escalating risks to senior PSPV leadership and overseeing the development and implementation of...

  • Head Risk Management

    hace 1 mes

    Barcelona, España Novartis Farmacéutica A tiempo completo

    Responsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco- and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and implementation of...

  • Head Risk Management

    hace 1 mes

    Barcelona, España Novartis Farmacéutica A tiempo completo

    Responsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco- and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and implementation of...

  • Head Risk Management

    hace 1 mes

    Barcelona, España Novartis Farmacéutica A tiempo completo

    Responsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco- and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and implementation of...

  • Head Risk Management

    hace 1 mes

    Barcelona, España Novartis Farmacéutica A tiempo completo

    Responsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco- and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and implementation of...

  • Head of Risk Management

    hace 7 horas

    Barcelona, Barcelona, España Innovative Medicines A tiempo completo

    Job Summary: We are seeking a seasoned professional to lead our Risk Management function within Innovative Medicines. As the Head of Risk Management, you will be responsible for establishing and maintaining a robust risk governance framework, identifying and managing risks within our Vigilance System and Quality Management System.About the Role:Develop and...

  • Global Head, Aggregate Reports and Risk Management

    hace 9 horas

    Barcelona, Barcelona, España Novartis A tiempo completo

    About the RoleThe Global Head, Aggregate Reports and Risk Management, leads a team of Senior Risk Management and Aggregate Reports Specialists in the development of robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned high-priority products/therapies, aligned with the benefit-risk profile of the products and supported by...

  • Global Head, Aggregate Reports and Risk Management

    hace 6 horas

    Barcelona, Barcelona, España Novartis A tiempo completo

    About the RoleThe Global Head, Aggregate Reports and Risk Management, leads a team of Senior Risk Management and Aggregate Reports Specialists in the development of robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned high-priority products/therapies, aligned with the benefit-risk profile of the products and supported by...

  • Head of Options Risk Management

    hace 2 días

    Barcelona, Barcelona, España Empresa Reconocida A tiempo completo

    About the Role**Head of Options Risk Management**We are seeking an experienced professional to lead our options risk management program. As a key member of our team, you will be responsible for monitoring, analyzing, and reporting on credit and liquidity risk arising from FX option structures entered by our clients.Key ResponsibilitiesOversee the...

  • Head of Options Risk Management

    hace 1 día

    Barcelona, Barcelona, España Empresa Reconocida A tiempo completo

    About the Role**Head of Options Risk Management**We are seeking an experienced professional to lead our options risk management program. As a key member of our team, you will be responsible for monitoring, analyzing, and reporting on credit and liquidity risk arising from FX option structures entered by our clients.Key ResponsibilitiesOversee the...

  • Head Risk Management

    hace 3 meses

    Barcelona, España Novartis Farmacéutica A tiempo completo

    .Responsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco- and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and implementation of...