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Patient Safety Manager

Sandoz México - Ciudad de México, Ciudad de México

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Descripción del trabajo

Job DescriptionSandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable biosimilar and generic medicines. As we move forward on this new and ambitious path, unique opportunities will arise, both professionally and personally. Join us—the future is in our hands Major Accountabilities End to end management of assigned pharmacovigilance processes across Sandoz business units -Responsible for ensuring compliance to global regulatory requirements with maximum efficiency -Lead assigned cross functional patient safety projects -Author and maintain procedural documents for assigned processes and drive continuous improvement by alignment of relevant stakeholders globally and locally -Develop and maintain training material and communications for Sandoz group and third party associates -Support impact assessments on emerging regulations and ensure ongoing compliance to global regulatory requirements -Lead assigned process improvement initiatives including IT projects/systems (leading enhancements and managing releases) -Analyze the impact of other process and organizational changes -Work in collaboration with other functions to produce compliance reports and complete quality checks to monitor regulatory compliance as well as compliance to internal requirements. In the case of any delays, investigate the root cause and develop and implement corrective and preventative actions. Measure effectiveness of actions taken -Act as a subject matter expert during audits and inspections (e.g. FDA and EMA), lead the preparation of responses to findings and the development and implementation of corrective and preventative actions. Resolve queries from other functions and Country Organizations (COs) related to assigned processes and act as a consultant on regulatory requirements. Mentor and train new starters -Distribution of marketing samples (where applicable) Key Performance Indicators Adherence to Sandoz policy and guidelines -Project & stakeholder feedback -Operational risk mitigation and audit/inspection findings -Quality and timely reporting of KPI and safety reports/updates -Results of audits/inspections Minimum RequirementsWork Experience: Functional Breadth. Managing Crises. People Challenges. Project Management. Operations Management and Execution. Collaborating across boundaries. Skills Databases. Employee Training. Pharmacovigilance. Project Management. Reporting. Safety Science. Languages English. Why Sandoz? Generic and biosimilar medicines are the backbone of the global pharmaceutical industry. Sandoz, a leader in this sector, provided more than 900 million treatments to patients in over 100 countries in 2024. Through investments in new development capabilities, production facilities, acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients access high-quality, affordable medicines in a sustainable way. Our open and collaborative culture is powered by talented and ambitious colleagues in an agile and collegial environment with impactful, flexible, and hybrid careers—where diversity is welcomed and personal growth is supported. Commitment To Diversity And Inclusion We are committed to creating an exceptional and inclusive work environment and diverse teams that represent the patients and communities we serve.

Creado: Jue, 01 de Ene de 1970

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