- Single point of accountability for the end-to-end CEP process and responsible for operationalizing the CEP policy through development and maintenance of quality oversight processes and evolution of training needs, in close collaboration with the CSS Training Lead, to ensure a deep understanding of the CEP process to drive compliance across all marketers globally - As a Single Point of Contact (SPOC) for CEP, CIT and Social Listening related matters in the North America Region, provide thought leadership, oversight and drive increased accountability from BUs- Sponsor and endorse changes to the CEP policy and governance structures; ensure appropriate interpretation of policy and compliance requirements to drive implementation in partnership with the CSS Centers of Excellence (COE) and Regional CSS Leads- Accountable for ensuring all CEPs globally are accounted for in the inventory and process controls are in place to ensure proper AE reporting from these programs- Accountable for actively monitoring regulatory environment in order to identify regulation changes that will impact the CEP Policy and procedures; is responsible for reflecting any regulation changes, in cooperation with Safety Policy, to ensure all CEPs globally are compliant with latest regulations- Chair and participate in key governance forums and advisory boards with senior leadership from commercial, medical, legal, regulatory, and safety organizations to drive compliance with the CEP policy and procedures and maximize business benefit of CEPs. - Maintain quality oversight and metrics tracking for all CEPs in scope - Partner with Safety, Regulatory, Medical Quality Oversight, Medical Quality Assurance and Legal Divisions to ensure audit and inspection readiness, audit review, oversight maintenance, and remediation plan monitoring

- Single point of accountability for the end-to-end CEP process and responsible for operationalizing the CEP policy through development and maintenance of quality oversight processes and evolution of training needs, in close collaboration with the CSS Training Lead, to ensure a deep understanding of the CEP process to drive compliance across all marketers globally - Sponsor and endorse changes to the CEP policy and governance structures; ensure appropriate interpretation of policy and compliance requirements to drive implementation in partnership with the CSS Centers of Excellence (COE) and Regional CSS Leads- Accountable for actively monitoring regulatory environment in order to identify regulation changes that will impact the CEP Policy and procedures; is responsible for reflecting any regulation changes, in cooperation with Safety Policy, to ensure all CEPs globally are compliant with latest regulations- Chair and participate in key governance forums and advisory boards with senior leadership from commercial, medical, legal, regulatory, and safety organizations to drive compliance with the CEP policy and procedures- Maintain quality oversight and metrics tracking for all CEPs in scope - Partner with all Regional Presidents, Commercial Operations Leads and others to ensure that CEPs follow proper policy for safety reporting, and build and sustain strong collaborative working relationships - Partner with Safety, Regulatory, Medical Quality Oversight, Medical Quality Assurance and Legal Divisions to ensure audit and inspection readiness, audit review, oversight maintenance, and remediation plan monitoring- Accountable for all end-to-end processes, services, governance and strategies for all global/above-market CEPs to ensure that programs are planned, executed, inventoried in compliance with regulatory requirements, and ensure process controls are in place to ensure proper AE reporting from these programs

• As a Single Point of Contact (SPOC) for CEP/CIT related matters, provide thought leadership, CEP/CIT oversight and drive increased accountability from BUs• Drive the end-to-end process, for ensuring CEPs are accounted for in the inventory, and process and controls are in place to ensure proper AE reporting from these programs.• Drive the end-to-end process, for ensuring CIT tools are accounted for in the inventory, and process and controls are in place to avoid late AE reports.• Ensure the execution of all CAPA commitments for the CEP/CIT process across the organization. • As a member of Regional GCO LT, get alignment with GCO Leads to remain embedded with business priorities• Manage network of Local CEP/CIT Leads in region• Train Local CEP/CIT Leads to provide design support and training in CEP Process to Program Owners• Train Local CEP/CIT Leads to provide training in CIT Policy and processes• Provide thought leadership to the Local Leads to develop and implement best practices from the company and the industry to ensure level 1 quality across CEPs• Work with Local Leads in identifying and filtering best practices and ideas to improve the CEP/CIT process• Implement best practices and initiatives promoted by CoE and communicate changes to Policies to Local CEP/CIT Committee and CEP/CIT Lead• Keep track of CEPs in region, providing status and trends around CEPs to CoE and stakeholders• Monitor changes in country regulations for CEPs• Liaise with MQA/MQO to review audits, maintain oversight, support inspection readiness and monitor post-audit remediation plans• Actively resolve outstanding CEP/CIT issues with functional areas (e.g. Regulatory, Legal, Compliance) and maintain Vendor Oversight Lead informed• Support the activities of vendor oversight as needed• Act as a catalyst in creating a global community around CEPs / CIT Tools and incorporate CEP/CIT compliance in company culture

• Manage the case-flow process across a multi-functional therapeutic team to ensure timely and accurate processing of adverse event cases to meet corporate and regulatory reporting requirements.• Provide oversight and guidance to Safety Surveillance Associates and Safety Surveillance Specialists on review and processing of adverse event reports.• Manage the team’s case processing to ensure complete and timely submission to the PSSR aggregate reports group.• In cooperation with the Therapeutic Area Head and Business Planning Leads, manage available resources to ensure effective processing of PSSR caseload, processing cases when necessary.• Take responsibility for implementing the corrective actions resulting from timeliness or quality issues associated with case processing.