Analyst, GCM Vigilance Reporting

Job Description

Team: Quality

Designation: Analyst, GCM Vigilance Reporting

Location: Chennai, India

Position Summary

The position is responsible for managing device or pharmaceutical complaints and adverse events globally. Duties may include the following: initial triage of complaint files, assessments of reportability, escalating customer advocacy events, submitting regulatory reports in accordance with applicable regulations, referring potential safety cases to applicable department, obtaining additional information for events, providing updates to reports, and assuring timely processing of complaint files with regards to regulatory reporting.

Essential Duties & Responsibilities

• Responsible for evaluating complaints from patient safety perspective and completing regulatory reporting decisions per reporting requirements globally.
• Responsible for creating and submitting regulatory reports to the FDA and/or Regional Competent Authority.
• Responsible for obtaining additional information for events as needed.
• Responsible for escalating and/or assisting with customer advocacy issues as they occur.
• Manages the complaint through life-cycle from registration, sample retrieval, follow-up, investigation and closure when required.
• Provide appropriate accurate information to customers during information gathering processes and within replies. (verbal and/or written)
  
  

Knowledge, Skills & Qualifications

• Experience with or knowledge of medical terminology and how medical/pharmaceutical products are typically used in a clinical setting.
• Must be able to communicate effectively with internal and external customers.
• Demonstrate ability to collect, analyze and interpret complaint and adverse event information.
  
  

Education And Experience

• Required: Graduate of Science or Medical Engineering or Graduate of Allied Science.
• Preferred: Bachelor of Science Degree in Nursing, Bio-Medical Engineering, Pharmacy, Medical Technology/ Clinical Laboratory Science and experience in a health care environment, and/or within a quality/compliance/regulatory organization in an FDA regulated business.