Countries & Regions Operational Excellence Senior Manager - Novartis
As an accomplished leader in Operational Excellence within Patient Safety & Pharmacovigilance (PS&PV), I bring over a decade of progressive experience driving process optimization, compliance, and cross-functional transformation in the pharmaceutical industry. My career at Novartis has been defined by a commitment to quality, innovation, and strategic impact—delivering measurable improvements in pharmacovigilance systems and business practices across multiple countries and regions.
In my current role as Countries & Regions Operational Excellence Senior Manager, I serve as a key representative in global PS&PV governance, critically assessing and endorsing process changes, and overseeing initiatives that optimize resources and elevate compliance standards. I have successfully led and supervised complex projects, designed and implemented new processes, and developed robust metrics to ensure quality and efficiency. My collaborative approach enables effective partnerships with global, regional, and local stakeholders, fostering a culture of continuous improvement and regulatory excellence.
I am passionate about building and leading high-performing, cross-functional teams, and have a proven track record in managing multi-disciplinary projects, navigating matrix organizations, and influencing at all levels. My expertise spans strategic planning, risk management, regulatory compliance, and the development of innovative tools that enhance pharmacovigilance operations.
Fluent in English and Spanish. I am recognized for my strong communication skills, problem-solving mindset, and ability to drive alignment between local and global functions. I am now seeking to leverage my experience and vision in a global leadership role, where I can further contribute to the advancement of patient safety, regulatory compliance, and operational excellence on a worldwide scale.
Strategic leadership in global pharmacovigilance and operational excellence
Proven ability to design, implement, and govern complex processes and SOPs
Expertise in risk assessment, compliance, and regulatory requirements
Track record of successful project and change management across regions
Strong stakeholder engagement and cross-functional collaboration
Talent development and team leadership in international environments
Multilingual communicator with a focus on quality, results, and innovation
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-Reports to Country Safety Lead or Safety Team Lead or Safety Officer (depending on local organization and safety group size) Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer’s products and to meet regulatory requirements. Determination of local submission of individual and, where appropriate, aggregate safety reports - Carry out case processing activities -Review, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments • Review case criteria to determine the appropriate workflow for case processing -Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately -Write and edit the case narrative -Determine and perform appropriate case follow-up, including generation of follow-up requests -Review processed cases to verify accuracy, consistency, and compliance with process requirements, and review case data for special scenarios -Liaise with key partners, locally , and other stakeholders regarding safety data collection and data reconciliation -Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database -Determine reporting applicability of scheduled reports , ensuring adherence to regulatory requirements -Consistently apply regulatory requirements and Pfizer policies -Participate, as appropriate, in local, internal and external safety activities
-Individual Case Safety Reports management, tracking and monitoring of adverse events. -Book in data entry and reporting Adverse events and Serious adverse events in Argus Affiliate (Oracle) database. -Contact with patients/health professionals to monitor the Adverse Events. -Analysis of causality and severity of Adverse Events. -Analysis of quality-associated issues/ Adverse Events and communication to the proper sector of the company. -Adverse Events coding, medical records and medications. -Narrative and reviews of relevant security. -Formulation of follow-up, Clinical Research Associates queries and delivery to investigator and centers. -Constant training in the area nationally and internationally. -Analysis and reporting of AEs. -Preparation of documents for regulatory unit national and international. -Deadlines for compliance with local regulatory units and abroad. -Consistent application of regulatory requirements and company policies. -Training and monitoring of activities. -Training in Pharmacovigilance responsibilities to staff call center marketing programs and company´s personnel. -Quality control processes of data entry in Argus database.
PhD degree. Title: “Study of the role of the PD-1 pathway on NK cell inmmune response and of the immunological mechanisms induced by Th9 cells against M. tuberculosis infection”. Department of Biological Chemistry, School of Sciences. University of Buenos Aires. Buenos Aires, Argentina. Calification: excellent.
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