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CEP Business Process Owner & Global Programs Lead


New York, NY
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Job Details

The CEP Business Process Owner (BPO) and & Global Programs Lead will be the single point of accountability for the global end-to-end CEP business process and responsible for operationalizing the CEP policy. The BPO will sponsor and drive endorsement of changes to the CEP policy and drive the implementation of its compliance requirements globally.

The Lead will also be accountable for end-to-end support for all global/above-market CEPs. The role will implement processes, services, governance and quality oversight to ensure that all CEPs in scope are planned, executed, and inventoried in compliance with regulatory requirements. Within these global/above-market CEPs, the Lead will oversee all aspects of audit and inspection readiness and lead effective implementation, management, and remediation support of Corrective and Preventive Actions (CAPAs). The Lead will also work to assess global CEP vendor performance to drive excellence. The role will report into the Global CSS Lead.

**CEP Business Process Owner**

+ 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 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. Governance forums and advisory boards include: CEP, CIT & SLP Steering Committee; CEP, CIT & SLP Governance Committee; CEP, CIT & SLP Operations Committee; CEP, CIT, & SLP Quality Oversight Committee

+ 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 adjusting quality processes and training approaches appropriately, based on outputs and/or findings from audits and inspections, to ensure the end-to-end process for operationalizing the CEP policy is driving compliance across the regions and markets

+ Drive evolution of the end-to-end CEP processes by proactively monitoring the regulatory environment and gathering industry and regulatory insights to anticipate future demands on Pfizer and develop solutions to feed into CO strategy and direction

+ Lead cross-functional working groups to proactively identify trends, potential compliance risks, and continuous improvement efforts globally; develop thought leadership and champion best practice sharing with Regional and Local CSS Leads to increase efficiency, awareness and overall compliance with CEP processes

+ Champion aggressive communication and best practice sharing that drives better adherence to global pharmacovigilance standards across the commercial organization

+ Oversee input of CEP volume forecast from all markets and regions to support the development and evolution of CSS demand management model

+ Champion best practice sharing amongst Regional and Local CSS Leads to identify and filter ideas to improve the global CEP process

+ Act as a catalyst in creating a global community on CEPs and incorporating CEP compliance into the Pfizer company culture

**Accountability for all Global/Above Market CEPs**

+ 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

+ Act as Single Point of Contact for all matters related to the development, approval, execution and close-out of global/above-market CEPs

+ Drive consistent quality standards and effectiveness measures across global/above-market CEPs in line with global quality plans and quality by design guidance

+ Lead analysis of global/above-market CEPs to develop actionable insights; collaborate with CSS COEs, commercial leadership, and key CEP stakeholders to translate insights into enhancements to the end-to-end processes and infrastructure of global/above-market/multi-market CEPs

+ Lead benefit, cost and risk assessment activities in country/cluster to support the business in making informed investment decisions on global/above-market CEPs

+ Escalate risks and issues to CSS and commercial leadership to decrease compliance risks associated with global/above-market/multi-market CEPs

**Audit, Inspection, and Remediation for Global/Above Market CEPs**

+ Oversee all aspects of audit and inspection readiness for all global/above-market CEPs and liaise with CSS Quality Implementation Global Center of Excellence to drive clear and consistent communication, documentation, training, inspection readiness plans, processes and controls

+ Lead effective implementation, management, and remediation support of Corrective and Preventive Actions (CAPAs) as per Pfizer's requirements for all global/above-market CEPs

+ Ensure appropriate and timely execution and tracking of all CAPA commitments for global/above-market/multi-market CEPs as per Pfizer's requirements

+ Engage with Business Unit leaders and other functional areas (e.g. Regulatory, Legal, Compliance) to resolve quality and compliance issues related to global/above-market CEPs

**Vendor Performance Management for Global/Above Market CEPs**

+ Work in partnership with the business and global CSS Center of Excellence to assess global CEP vendor performance, optimize vendor mix and track vendor compliance in close partnership with global procurement to drive vendor excellence

+ Accountable for ensuring that global/above-market CEP vendors not complying with CEP processes and requirements are identified and applicable CAPAs are defined

**People Management**

+ Provide leadership, mentoring and development guidance to colleagues and ensure effective leadership and development throughout the CEP function


+ Bachelor's degree is required and Master's degree is preferred

+ 15+ years' experience in pharmaceutical industry

+ Experience in managing global shared services operations, preferably in Pharmacovigilance or Safety functions

+ Deep understanding of Pfizer's pharmaceutical business operations and products

+ Understand the fundamentals of drug safety and risk management (e.g. AE reporting), as well as CEP / CIT processes, policies and procedures

+ Proven ability in managing day-to-day planning and operational activities

+ Strong collaboration/relationship-building skills and ability to engage stakeholders across multiple functions

+ Excellent communication skills with an ability to respond with professionalism in verbal as well as written communications

**Skills and Knowledge**

+ High level of strategic and analytical skills

+ Demonstrated leadership ability in complex, cross-functional and cross-regional initiatives

+ Ability to synthesize problems and develop innovative solutions and strategies

+ Ability to drive execution of strategies, acting independently and/or in collaboration with other stakeholders as appropriate

+ Ability to engage and collaborate effectively with stakeholders from different areas and in complex organizational environments

+ Ability to communicate, persuade, influence and operate effectively across business functions and organizational levels

+ Ability to take initiative within strong team-oriented environment

+ Ability to anticipate issues/needs and to work proactively to address them

+ Ability to work at all levels, from local managers up to and including Regional Presidents

+ Ability to work effectively and collaboratively with Commercial Pharmacovigilance Organization

+ Ability to work flexible hours (early AM, overtime, etc.) when needed

**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

**Other Job Details:**

+ **Last Date to Apply for Job: 2/20/2018**

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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