ROLE RESPONSIBILITIES 
CQO policies Contact
Act as single point of contact and local subject-matter expert for country management forum or equivalent governance body to drive overall culture of quality and compliance of CEPs, CIT tools and SLPs within country/cluster
Closely collaborate and engage with Regional CQO Lead as first point of contact for guidance and escalation point to drive compliance in country/cluster across all CQO policies , identify opportunities for improvement and share best practices Partner with CQO Business Process Owners / Global CQO Center of Excellence to implement CQO policies and strategies in country/cluster, as well as oversee changes in local regulations relevant to CQO Foster strong partnership with Business Units, Commercial Operations, Safety, Medical Quality Oversight etc. to represent CQO as a thought leader in country/cluster meetings and forums and demonstrate value proposition of CQO Provide inputs on CEP, CIT and SLP volume forecasts to improve demand management in collaboration with global CQO Center of Excellence Design and implement local operating plan in collaboration with the global CQO Center of Excellence
Local CQO Process Ownership and Quality Monitoring Manage end-to-end process from design, development, approval, execution and close-out of all CEPs, CIT tools and SLPs in country/cluster to ensure compliance with Pfizer policies
Act as a subject-matter expert providing in-depth knowledge and consultancy to CEP, SLP Owners and CIT Tool Owners to design programs and tools appropriately to ensure compliance Chair and facilitate local committee approval meetings and any other additional meetings between Program/Tool Owners and local approvers to secure agreement on programs and tools for timely approval Drive consistent quality standards and effectiveness measures across CEP, CIT tools and SLP in line with global quality plans and quality by design guidance Lead benefit, cost and risk assessment activities in country/cluster to support the business in making informed investment decisions on CEP, CITs and SLP Ensure appropriate escalation of risks and issues to Regional CQO Lead as well as provide timely status updates and reports to CLF or equivalent governance body and other stakeholders.
Audit and Inspections Oversee all aspects of audit and inspection readiness and liaise with CQO Quality Team to drive clear and consistent communication, documentation, training, inspection readiness plans, processes and controls
Proactively drive awareness and upskill Program Owners and Tool Owners to fulfill their role during audits and inspections Monitor country/cluster audit and inspection outcomes, support development of any necessary remediation, share learnings and flag areas of concern, Lead effective implementation and management of Corrective and Preventive Actions (CAPAs) as per Pfizer¡¯s requirements Continuously monitor CAPA performance within country/cluster in collaboration with Regional CQO Lead and act as expert on CAPA remediation in collaboration with local Medical Quality Oversight organization Oversee CEP, CIT and SLP reporting, with support from CQO Operations Manager where possible, and actively follow up with Program and Tool Owners to resolve any compliance issues as well as resolve outstanding issues with correspondent functional areas (e.g. Regulatory, Legal, Compliance) Responsible for escalating any compliance issues and appropriate reporting to Regional Quality Forum
Vendor Oversight Drive vendor excellence and work in partnership with the business and global CQO Center of Excellence to assess, evaluate and maintain accurate vendor performance data and preferred vendor lists
Ensure that vendors not complying with CEP processes and requirements are identified and define applicable CAPAs Oversee CEP vendor management and procurement systems, where possible
Training Lead training and upskilling of key stakeholders including CEP and SLP Program Owners, CIT Tool Owners, vendors, approvers, marketers and field force colleagues to increase understanding and awareness of CEP, CIT, SL policies and CQO processes and  enhance compliance, quality and pharmacovigilance capabilities, in line with Global CoE guidance
Be accountable for monitoring and facilitating local training completion of mandatory CEP, CIT and SLP training courses among training audience, in collaboration with the business and enabling partners Lead on local training audience maintenance processes in line with Global CoE guidance Provide feedback to global CQO BPO / Training CoE Lead on training assets, process and communication effectiveness   Best Practice and Continuous Improvement  Act as local champion to drive implementation of global and regional CQO projects and initiatives
Engage actively with the broader global CQO community and Center of Excellence to exchange best practices and lessons learned and promote collaboration across countries
Engagement across GCO Korea Responsibilities Facilitate GCO Korea Leadership meetings in way of efficient operation with appropriate agenda
Coordinate the follow up processes of decisions from GCO Korea leadership meetings and GCO related meetings Build and sustain strong collaborative working relationship across GCO Korea and Pfizer Korea / IDM GCO Communicate closely with GCO Korea leadership team to improve processes between clients, workstream, and GCO IDM and Global.   Cordinate with GCO Korea leadership team for issues resolution
Strategy Development for GCO Korea  Coordinate operations of the project which GCO lead initiates and lead project management across GCO Korea
Supports GCO Korea Lead in organizing, planning and implementing strategy and objectives are met by effective business operations Roles as communications vehicle related matters with GCO Korea Lead  QUALIFICATIONS
Qualifications Bachelor''s degree required
Min. 5 years of professional experience which includes 3+ years in CEP/CIT experience preferred or transferable experience  Preferred subject matter expert(SME) in country or regional role and people management experience  Detail-oriented with strong organizational skills and a proven ability to prioritize and work independently to complete quality work on a timely basis Ability to work effectively and collaboratively with CEP / CIT Center of Excellence Experience in commercial operations and/or sales & marketing is considered as a plus
Skills and Knowledge Understand the fundamentals of drug safety and risk management (e.g. Adverse Event reporting), CEP processes, policies and procedures
Strong analytical skills ability to analyze information, draw insights and recommend improvements ability to synthesize problems and develop innovative solutions and strategies Ability to demonstrate strong facilitation and collaboration skills Proficient in project management skills Proven ability to drive execution of strategies Proficient in common technical tools (e.g. Microsoft Office) Strong written and spoken communication skills in English Ability to build strong formal and informal relationships  |