Quality Event Assessment and Investigation Lead
Why Patients Need You
Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.
What You Will Achieve
As a Quality Event Assessment and Investigation Lead (QEAIL), you will be accountable for:
Assessing and categorizing submitted GCP Quality Events (QEs) to determine if the Significant Quality Event (SQE) threshold has been met, or
Managing a confirmed SQE case through the investigation process including root cause analysis.
You will ensure submitted QEs are assessed promptly and then that the investigations are conducted thoroughly, within required timelines and to compliance requirements including ensuring the adequacy of root cause analysis and appropriateness of communication regarding the case. You will lead the SQE team in the development of appropriate Corrective and Preventative Actions (CAPA) and assign completion dates to action owners that ensure actions are progressed quickly to completion.
How You Will Achieve It
Quality Event Assessment
You will ensure that each submitted QE is reviewed based on the established criteria, is categorized appropriately, and completed within the required time frame to ensure that events are appropriately qualified, enabling expedited investigation where necessary.
Significant Quality Event Investigations
You will ensure that each confirmed SQE is investigated appropriately including ensuring investigation timelines are met and that appropriate pre-work is done on the case the enable an investigation with appropriate quality outcomes including a well written case summary (meets defined quality standards) which can be used in a regulatory inspection. Case summaries should not require more than a single round of review by an approver.
Case documentation will be complete and accurate and filed as necessary to ensure inspection readiness. You will appropriately escalate concerns regarding the progress of a case so that it can be addressed and resolved in a timely manner. You will be responsible for managing all extension requests for cases, actions and CAPA effectiveness checks so that approvers are given adequate time to approve before the case goes overdue.
BS – 10 years or equivalent
MS/MBS – 5 years or equivalent
Minimum of 5 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality, GxP Quality, and/or regulatory.
Regulatory inspection experience
Process and system management experience
Detailed knowledge of clinical trial processes and relationships required
Knowledge of GCP requirements and applicable SOPs and regulations
Project management, administrative, and technical capabilities are required, as well as effective verbal and written communication skills
Strong background in continuous improvement methodology (ie Lean Six Sigma) preferred.
Eligible for Employee Referral Bonus: YES
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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.
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.Medical