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