Data coordinator

Job Summary

The Data Specialist Coordinator for Vigilance is responsible for accurate vigilance data compilation, documentation, organization, and database coordination of the KabiSafe / SAP / gCMW database systems.

The vigilance information on adverse event information is used globally within MedTech for reporting to Health Authorities, including the FDA.

Data is used to support FDA / cGMP audits, and for signal detection and evaluation of potential safety and quality issues.

This position ensures compliance with FDA regulations, cGMP, and both global and local SOPs, and adherence to regulatory and FK Vigilance.

This position will assist in the tracking of adverse events and Field Corrective Actions (FCA's), the accuracy of which ensures the facility's cGMP / FDA compliance status.

Collaborates cross-functionally with other functional areas within Fresenius Kabi MedTech, and Fresenius Kabi partners globally to ensure the responsibilities are met.

Responsibilities

• Data entry and processing of individual adverse event reports (Medical Device Reports - MDRs) in the vigilance database system(s), ensuring accurate electronic documentation.
• Creates and reports on ADEs, MDRs and Field Alert Reports (FARs) to the FDA. This includes tracking, follow up and closure activities of each event, along with analyzing and evaluating for accuracy of information.
• Assists in the compiling of MedTech FDA 483 responses and monthly status reports to assist the Regulatory organization with file publishing.
• Triages Adverse Event Reports; Retrieval of and dissemination of adverse event data from all sources to the appropriate Vigilance and / or Quality personnel.
• Assists with special projects and initiatives for the Quality Department.
• Contributes when needed to the investigation of queries relevant to medical information requests.
• Data entry and information retrieval in the KabiSafe database.
• Maintains a courteous, cheerful, and cooperative demeanor at all times, with both internal and external customers.
• Additional tasks and responsibilities as required.

REQUIREMENTS :

• High School Diploma and three years of medical experience required.
• Medical Device and / or Pharmaceutical company product quality complaint and / or adverse event reporting experience preferred.
• Excellent verbal and written communication skills required.
• Ability to interface with all levels of management (in person, on the phone, and in written communications)
• Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures.
• Knowledge of FDA Quality Systems and Medical Device Reporting regulations (21 CFR 803, 820 & 211; Part 11) plus ISO 13485 / MDSAP, ISO 9001, and EU MDR preferred.
• Ability to understand and interpret complex medical, clinical and adverse event data.
• Position requires a high degree of accuracy, must be able to work independently, prioritize, analyze and problem solve.

Critical thinking skills are a must.

• Ability to work in a fast-paced environment and maintain internal and external compliance timelines, is required.
• Knowledge of PC systems and Microsoft Office Suite (Word, Excel, Office 365) required.
• Self-motivated and ability to work independently.
• Must be able to prioritize and multi-task with minimal supervision.
• Exceptional customer focus.
• Strong interpersonal skills and the ability to work with cross-functional teams.
• Able to effectively coordinate multiple tasks on a daily basis.
• Detail oriented with good organizational skills.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Last updated : 2024-02-23