-Lead a team of Clinical Safety and Risk Management medical associates accountable for all aspects of safety assessment and risk management for marketed products.-Oversee the work of Safety physicians and provide mentoring and guidance ensuring the best possible understanding of the safety profile of their assigned products and effective completion of their deliverables -Oversee the work of medical associates and provide mentoring and guidance ensuring the best possible understanding of the safety profile of their assigned products and effective completion of their deliverables -Responsible for the overall clinical risk management and safety surveillance of Established products. Including safety monitoring and assessment of safety information ensuring completeness of safety information in worldwide package circulars. -Responsible for the development of post-market risk management plans and pharmacovigilance strategies

-Responsible to implement a team of safety associates to support established products -Oversee the work of CSRM medical associates and provide mentoring and guidance ensuring the best possible understanding of the safety profile of their assigned products and effective completion of their deliverables -Responsible for the overall clinical risk management and safety surveillance of Established Products. including safety monitoring, assessment of safety information and completeness of safety information in worldwide package circulars. -Responsible for the development of post-marketing risk management plans and pharmacovigilance strategies.-Chair the Risk Management and Safety sub team for assigned products. -Partner with stakeholders to ensure efforts are aligned to meet global risk management strategies for assigned products.

• Responsible and accountable for the organization and strategic direction of Global PV case management operation across Merck Data Management Centers (Asia, Europe and South America)• Ensure that the Global Pharmacovigilance case processing operation effectively processes all worldwide Adverse Events cases according to documented quality/compliance and cycle-time performance measures (including industry benchmarks) and consistent with regulatory requirements for AE reporting. • Vendor management and oversight. Responsible to ensure KPIs (quality, compliance, Productivity, resource utilization and cycle times) are met. Responsible for contract renewal (RFI, RFP)• Global resource planning and capacity management to manage over 350,00 annual AE reports • Budget planning and management (annual budget over $13 US million) • Make career development opportunities available for the organization with over 600 contributors (Managers and Individual contributors)• Sponsor/lead cross functional projects to transfer operations/processes from headquarters to the Data management Centers• Process Simplification and process improvement • Set up new strategic location for new data management centers • Support PV audits and Inspections

- Responsible for MSD PV AE case Management operation of Clinical Studies and Post Marketed AE cases - Manage performance of Global Data Management Centers and CRO to assure the KPIs accomplishments: Quality, compliance, productivity and cycle time. (China, Poland, Colombia, India)- Oversight global DMC process owner network (Training, Workload, Review, case processing, Quality, Compliance)- People management and Development Global PV case Processing Team (22 managers + 400 people) - Global resourcing strategy planning- Process Improvement - Vendor management- Development of Cross functional projects to transfer/implement different operations in the Data Management Center

- People management and development (3 managers and 13 direct reports)- Oversight of Colombia DMC PV case processing operation (Quality, Compliance, Training, Workload, Review)- Transition of new business processes to the Global DMC model - Development of resourcing business models for new processes and systems - Impact assessment of new system implementation

- Responsible for assuring the compliance of Adverse events worldwide reporting time lines- Responsible for maintaining the Quality of the AE reports- Create strategies to manage the workload in the group- Medical training for pharmacovigilance coordinators.- People management and development (13 direct reports)

•Responsible for the process of AE reporting to regulatory agencies in Colombia, Ecuador and Venezuela accordingly to local regulations•POC for Physicians and patients for AE reporting and safety issues •Pharmacovigilance training for sales force and new employees•Responsible for supporting medical activities for Marketing and Sales in Colombia •Pharmacovigilance speaker in good clinical practices forum

•Responsible for supporting medical activities for Marketing and Sales •Supervise ethics, integrity and fulfillment of medical policies and procedures related to regulations, both corporative and local in promotional materials. •Liaison between Research area (Merck Research laboratories) and Sales & Marketing Areas with the implementation of a tool for new investigator including KOL.•Design, coordinate and implement training programs supporting the launching of new products, new sales reps, and new medical evidence and medicine safety issues.•Responsible for Ecuador Medical – Legal Approval