Field Alert / Notification to Management Specialist
Hospira - Austin, TX

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          Field Alert / Notification to Management Specialist –

          Austin, Texas

          Aspire…to save others’ lives, while shaping your own

          Discover a new kind of career with a new kind of industry leader. Discover Hospira, the world’s leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 14,000 employees. Learn more at .

          What We Are Proud Of

          We at Hospira, Inc. feel rewarded by our hard work and take pride in knowing we’re on our individual career paths with a shared goal:

          Advancing wellness™, through the right people and the right products

          Primary Function:

          The Field Alert / Notification to ManagementSpecialist is responsible for content determination, development and submission to Hospira Corporate and the FDA, all Field Alerts and Notification to Management slides and follow-ups. This position performs a comprehensive review and disposition of information collected during the investigation of product complaints in accordance 21 CFR 211.198. In addition, this position prepares and submits Field Alert Notification Forms to the FDA in accordance with 21 CFR 314.81 when Hospira becomes aware of any event that may affect marketed drug products manufactured or distributed in the US. This position will track and report directly to the FDA status updates of FARs. This position will also be responsible for writing Notification to Management presentations and recommendation of field action to be taken.

          Major Duties and Responsibilities:

          1. Provides compliance oversight for all product complaint investigations assuring that thorough root cause evaluations are performed. Categorizes the root cause and determines if the complaint is confirmed for integration into a Field Alert Report or Notification to Management Presentation.

          2. Summarizes the complaint investigation to be reviewed by regulatory and/or third party auditors.

          3. Prepares Initial Field Alert Notification Forms (FARs) based upon the initial analysis of product complaints that indicate the potential that marketed drug products manufactured or distributed in the US are impacted.

          4. Prepares Follow up and Final FARs following the completion of root cause investigation.

          5. Assures that appropriate actions identified in product complaint investigations are completed or tracked within the CAPA system.

          6. Prepare Notification to Management slides and track meeting minutes action items to completion.

          7. Obtain and Track requests for Medical Assessments

          8. Responsible for Accuracy of Medical Assessments from a QA perspective to verify content is in alignment with data from the original complaint.

          Skills/Experience Education/Certification
          • Bachelor’s degree required.

          • 7-10 years of experience in a regulated industry (Pharma, Med Device, Nuclear or Aerospace). 3-5 years of experience within Quality (Device or Pharma) or Regulatory Affairs.

          • Strong self directive work practice

          • Strong written and verbal communication skills

          • Strong interpersonal skills at all levels within the organization

          • High level of organizational skills and independence

          • Strong judgment and decision making ability

          • Proficient knowledge of current Good Manufacturing Practices (cGMP) for a pharmaceutical industry.

          • Strong Negotiations Skills

          Hospira - 2 years ago - save job
          About this company
          178 reviews
          Hospira helps hospitals heal the hurting. The company makes specialty injectable pharmaceuticals (primarily generics) including...