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CSS Lead


Ryde, CA 95680
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Job Details

The Local CSS Leads supports Program Owners in identifying when a program or tool is a CEP or CIT, giving options of how to improve quality and mitigate safety reporting risks, and guiding them through the CEP / CIT process and related implications. Participates in the Local Committee, attending meetings, giving feedback on country CEPs and informing on global policies and procedures. Train Programs and Tool Owners and Approver on the relevant policies and procedures.

Serves as a feedback mechanism to Regional CSS Lead of best practices in order to promote efficiency and effectiveness in the CEP process. Prepares the CEP Report, acts as a point-of-contact for communications and issue resolution locally and ensures CEPs comply with Corporate Policy 902 and the associated procedures as well as with CIT policies. Supports activities of vendor oversight as needed.

It also supports CIT Tool Owners be compliant with the CIT process, raise awareness and solve related issues. The local CSS lead also supports social listening policy and monitors progress.


In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 essential responsibilities that highlight accountability and level of judgment required.

Program Owners support

+ Provide support to Program Owners in design phase and navigating the CEP process in a compliant manner

+ Monitor CEPs compliance during the conduct and close-up phases

CIT Tool Owner support

+ Provide support to CIT Tool Owners in navigating the CIT process in a compliant manner

+ Review, revise and/or approve Tool Owner submissions

+ Monitor adherence to CIT Policy by Tool Owners

CSS Training and Change Management

+ Provide thought leadership and periodic CSS updates in CMF or equivalent In partnership with CO Lead

+ Drive training of key stakeholders in CSS process (e.g. CEP POs, CEP Approvers, , Vendors, CIT Tool Owners & Approvers etc.)

+ Monitor training compliance in CSS process (e.g. Program / CIT Tool Owners, Vendors, etc.)

Local CEP / CIT Committee Management

+ Develop the agenda and logistics of the CEP / CIT Committees

+ Participate in the CSS Committees during approval meetings and mediate between the Program/CIT Tool Owner and the Committee's recommendations

+ Provide appropriate support for approval of multi-country CEPs

+ Best Practices and Improvement Initiatives

+ Identify and communicate to Regional CSS Leads best practices and improvement opportunities in the CSS process

+ Maintain active engagement with global CSS community to exchange best practices and drive continuous improvement efforts

+ Support Committee in the oversight of key metrics and quality measures

+ Review best practices resulting from programs conducted in the country

Policies and Procedures follow up

+ Communicate changes to CP 902, CP 902a, CIT, and Social Listening Policies to internal and external stakeholders

+ Timely communication of any newly developed guidances as a part of the continuous improvement efforts undertaken by CSS organization

+ Monitor changes in country regulations relevant to CP 902 and CP 902a and CIT policies and communicate them to Regional CSS Lead

Audits, Inspections and Quality Monitoring

+ Support countries to be prepared for audits and inspections

+ Monitor the implementation of CAPAs defined by MQO

+ Keep track of CEPs, providing status and trends to key internal stakeholders

+ Review of exception reports and follow up with POs for flagged programs until it is solved

+ Share CEP and CIT quality report results with Local CEP and CIT Committee and CMF or equivalent to build CEP / CIT awareness

+ Participate and be involved in post-audit meetings if findings cover CEPs or CIT Tools

Vendor Oversight

+ Support the activities of vendor oversight as needed in partnership with Global Procurement and CoE

+ Monitor Ariba for vendors being on-boarded for potential CEP engagements

+ Identify vendors not complying with CEP processes and requirements and define applicable CAPAs

CEP Issue Resolution and Transition

+ Actively resolve outstanding CEP tasks and issues with the correspondent functional areas (e.g. Regulatory, Legal, Compliance, etc.) and the PO

+ Support PO transition with the PO Manager to transition CEP ownership, even after the program end date

+ Identify issues of CEP Program Owner non-complianc e and support remdiation activities in conjunction with the Program Owner Manager

CIT Issue Resolution

+ Actively resolve outstanding CIT related tasks and issues with the correspondent functional areas (e.g. Regulatory, Legal, Compliance, etc.) and the Tool owner


Indicate qualifications that are job related, consistent with business necessity and necessary for the performance of an essential function of this role including: education/licenses/certifications, relevant experience (where legally permissible), technical and/or other job-related skills.


+ Bachelor's degree required

+ Min. 5+ years of professional experience; which includes 3+ years in CEP/CIT or transferrable experience

+ Demonstrated work experience in Commercial operations, Safety and/or Compliance

+ 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 global partners e.g. CEP / CIT Centers 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 oral communication skills

+ Ability to build strong formal and informal relationships

+ Language skills: fluent in local language and English

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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