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Field Alert Coordinator

Employer
Pfizer
Location
Rocky Mount, North Carolina
Start date
May 3, 2022

View more

Discipline
Clinical, Clinical Project Management
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Bio NC, Best Places to Work
Why Patients Need You

Everything Pfizer colleagues do each day is based on an unwavering commitment to quality and the delivery of safe and effective products to patients. Our science and risk-based quality compliance culture is flexible, innovative, and customer oriented. A career at Pfizer offers opportunity, ownership and impact. Pfizer colleagues across the world work together to positively impact health for all people. Pfizer colleagues have career growth and development opportunities that offer both individual and company success. In addition, Pfizer provides the opportunity to be part of a diverse, energized, engaged team and a culture with the core values of courage, excellence, equity and joy. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking highly talented individuals inspired by our vision to innovate to bring therapies to patients that significantly improve their lives. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of the Product Complaints team in the Pfizer-Rocky Mount site’s dedicated and highly effective Quality Systems team. You will serve as a primary contact for generation, processing and issuance of Initial, Follow-up and Final Field Alert Reports (FARs) to the FDA as required for quality and compliance related events. You will work closely with Investigators, the Product Complaints Manager, other site functional area colleagues as needed and above site senior management approvers (FAR / BPDR Center, Operating Unit Quality Operations Lead, Vice President of Quality Operations and Senior Corporate Legal Council) for preparation and approval routing of the FARs to ensure FAR issuance timing in compliance with regulatory and site procedure requirements.


FARs are a key element in the Quality and Compliance System with high visibility and review focus in regulatory inspections. On time issuance of thorough, accurate and well written FARs is extremely important for maintaining inspection readiness at the Rocky Mount site and achieving successful inspection results.

How You Will Achieve It
  • Facilitate Daily Triage meetings for review of complaint events, Retain sample defect events and Quality Notification Report events from Stability Laboratory Services to determine FAR requirements.
  • Coordination/Generation of Initial/Follow-up/Final FARs, assuring that timing requirements are met for issuance of Initial and Follow-up FARs.
  • Communication with key site personnel for any information required to generate the FARs and address review feedback.
  • Focused review of the investigation information and communication with the Investigator and other key contacts for each subject issue to ensure alignment between the FAR and the investigation
  • Communication with Senior Management reviewers/approvers regarding review feedback and alignment on updates required in the FARs.
  • Provide audit support with timely data preparation to address inspection requests related to Complaints, FARs and Market Actions.
  • Prep and issuance of Daily Notification to Management Reports for communication of significant product related quality, regulatory compliance and patient safety issues to the Site Quaility Operations Leader and the Operating Unit Quality Operations Leader
  • For quality defect events from products distributed to countries outside the US, perform an assessment to determine if notification is required to a Regulatory Authority for a distribution country outside the US and the timing requirement for the notification.
Qualifications

Must-Have
  • Bachelor's Degree and 0-2 years of experience
  • Capable of interfacing effectively with multiple levels of colleagues at the site and above site.
  • Demonstrated critical thinking skills and strong attention to detail and accuracy in writing and reviewing documents
  • Solid multi-tasking skills for efficient and effective completion of assignments with competing priorities and requirements and ability to transition smoothly when priorities are changed suddenly
  • Excellent written and verbal communication skills
  • Strong technical writing skills
  • Strong follow-up communication skills
  • Proficiency with Microsoft applications (Word, Excel, PowerPoint, Visio, etc.)

    Relocation support available

    Last date to apply: May 18th

    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.

    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.

    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.

    Quality Assurance and Control

    #LI-PFE

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