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FARs (Field Alert Reports) Coordinator

Company: Pfizer
Location: Saint Louis
Posted on: November 11, 2019

Job Description:

About the Job ROLE SUMMARY This position is responsible for timely completion and issuance of Initial, Follow-up and Final Field Alert Reports (FARs) for Meridian Medical Technologies, a Pfizer company. Role Responsibilities - Participation in Complaint Triage meetings for review of the complaint events to determine FAR requirements. - Coordination/Generation/Issuance 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. - Communication with Senior Management reviewers/approvers regarding review feedback and alignment on updates required in the FARs. - Review complaint investigations - Provide audit support with timely data preparation to address inspection requests related to Complaints, FARs and Market Actions. - Strong technical writing skills. - Solid analytical skills and attention to detail are important for this job function to ensure accuracy of the FARs and alignment of the FAR content with the investigation completed for the event. BASIC QUALIFICATIONS - Bachelor's Degree, preferably within Science/Engineering fields - 3-5 years of experience within a QA Role in a cGMP setting - Experience with complaint investigations preferred - Experience with Field Alert Report issuance preferred - Strong technical writing skills - Good organizational skills - Multi-tasking skills - Good analytical skills - Proficiency with MS Office applications (Word, Excel, PowerPoint, Visio, etc.) 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. The job is open only to Protected Individuals (as defined by 8 U.S.C. 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents ('green card holders'), Refugees and Asylees. Last Date to Apply for Job: October 25, 2019 Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Keywords: Pfizer, St. Louis , FARs (Field Alert Reports) Coordinator, Other , Saint Louis, Missouri

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