Analyst Job Opportunity at ICU Medical – Advance Your Career in Vigilance Reporting
ICU Medical is offering an exciting analyst job opportunity in Chennai for professionals interested in global vigilance reporting and regulatory compliance. This hybrid role is well-suited for candidates seeking medical jobs within a quality-driven environment, where managing patient safety, complaint handling, and regulatory reporting plays a critical role. Among current jobs in Chennai, this position provides exposure to global regulations and industry best practices at ICU Medical.
Job Details:
- Job Position: Analyst, GCM Vigilance Reporting
- Location: Chennai, Tamil Nadu, India (Hybrid)
About the Company:
ICU Medical is a global medical technology organization focused on improving patient safety through innovative medical devices and infusion therapy solutions. The company operates in a regulated environment, offering rewarding medical jobs that emphasize quality, compliance, and global regulatory standards.
Qualifications:
- Experience with or knowledge of medical terminology and how medical or pharmaceutical products are typically used in a clinical setting.
- Ability to communicate effectively with internal and external customers in a professional healthcare environment.
- Demonstrated ability to collect, analyze, and interpret complaint and adverse event information relevant to medical jobs in regulated industries.
Education:
- Required: Graduate of Allied Science.
- Preferred: Bachelor of Science Degree in Medical Technology/Clinical Laboratory Science, and experience in a healthcare environment and/or within a quality, compliance, or regulatory organization in an FDA-regulated business.
Position Summary:
This analyst job is responsible for managing device or pharmaceutical complaints and adverse events globally. Duties may include 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 the applicable department, obtaining additional information for events, providing updates to reports, and assuring timely processing of complaint files with regard to regulatory reporting.
Key Responsibilities:
- Responsible for evaluating complaints from a patient safety perspective and completing regulatory reporting decisions per global reporting requirements.
- Responsible for creating and submitting regulatory reports to the FDA and/or the Regional Competent Authority as part of this analyst’s job.
- 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 its life-cycle from registration, sample retrieval, follow-up, investigation, and closure when required.
- Provide appropriate and accurate information to customers during information gathering processes and within replies (verbal and/or written).
