Risk Management Manager

Novartis Farmacéutica; Ibiza; Presencial; EUR 45.000 - 80.000; Jornada completa

Descripción de la vacante

Una empresa farmacéutica de renombre busca un Gerente de Gestión de Riesgos para liderar iniciativas que identifiquen y categoricen riesgos en su sistema de Vigilancia. Este papel clave implica la supervisión de problemas de calidad, la colaboración con diversas funciones globales y el desarrollo de planes de acción para mitigar riesgos. Con un compromiso hacia la diversidad y la inclusión, esta posición ofrece la oportunidad de impactar positivamente en la seguridad de los pacientes y en el cumplimiento normativo. Si tienes experiencia en farmacovigilancia y habilidades de liderazgo, esta es tu oportunidad de unirte a un equipo innovador y comprometido.

Formación

• Mínimo 4 años de experiencia en la industria farmacéutica, especialmente en farmacovigilancia.
• Capacidad para interactuar con una amplia variedad de personas a todos los niveles.

Responsabilidades

• Monitorear y auditar el programa de vigilancia de medicamentos de la empresa.
• Desarrollar y mantener documentos de procedimiento relevantes.

Conocimientos

Gestión de Proyectos

Habilidades de Negociación

Habilidades de Presentación

Habilidades de Comunicación

Habilidades Analíticas

Mentoría y Coaching

Educación

PharmD

MSc en Ciencias de la Vida

Herramientas

AQWA

1QEM

Descripción del empleo

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.

About the Role

The Risk Management Manager leads activities and initiatives designed to identify and categorize risks that potentially impact the Vigilance system and the broader PS&PV organization as well as the preparation of action plans for PS&PV leadership endorsement. Ensure oversight of management of Patient Safety Quality Issues and Quality Events in AQWA / 1QEM.

Your key responsibilities, but not limited to :

• Through oversight and trending of the below areas;
• Receipt of Quality Issues and Quality Events
• Entry in to AQWA / 1 QEM
• Timely completion of investigations
• Implementation of appropriate CAPAs and availability of appropriate evidence
• Completion of effectiveness checks
• Timely closure in AQWA, / 1QEM
• Drive the development of actionable insights and mitigation plans to ensure that any opportunities for improvement are identified and acted upon as early as possible.
• Lead and support strategic projects related to Risk Management of the Novartis Vigilance System.
• Prepare / maintain guidance documents and training material to educate Patient Safety associates on the Quality Issue & Quality Event process.
• Monitor compliance of the Patient Safety organization to Quality Issue & Quality Event 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 CMO&PS organization.
• Collaborate with other Global Line Functions across Novartis Divisions and Third Parties to establish and meet joint accountabilities.
• Lead the development and maintenance of respective procedural documents including ownership of relevant PSMF sections and annexes.
• Support the review of emerging worldwide regulations, performing impact assessments, and driving process changes required to ensure ongoing compliance to global regulatory requirements.
• Act as a subject matter expert during audits and inspections, lead the preparation of responses to findings and the development and implementation of corrective and preventative actions.
• Prepare reports and / or presentations to document the outcome of risk assessments for the Process Governance and Risk Mitigation management team and escalate key findings to the Head Compliance and Risk Management and / or relevant governance or LT board.
• Support with management of the Operational Metrics & Risk Committee as the Secretary; scheduling the meetings, preparing the agenda and track and follow up on actions.

Minimum Qualifications :

• Minimum 4 years of experience in the pharmaceutical industry, particularly pharmacovigilance
• Experience in project management and demonstrated ability to lead work groups
• Ability to deal and interact with a wide variety of people at all levels.
• Strong negotiation, presentation and communication skills, and ability to operate effectively in an international environment and across functions
• Excellent analytical skills.
• Ability to mentor and coach

Educational Background :

PharmD, MSc Degree in Life Sciences or equivalent.

Commitment to Diversity & Inclusion :

Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.