Norstella Hiring Analyst, GCM Vigilance Reporting

Science Graduate Analyst Vacancy – Vigilance Reporting Chennai

Hiring Analyst for GCM Vigilance Reporting in Chennai. Science graduates with experience in safety, quality, or compliance preferred.

Intro Paragraph:
This role suits candidates who want to work at the intersection of product safety, regulatory compliance and global vigilance operations. The Analyst, GCM Vigilance Reporting supports the evaluation, documentation and regulatory submission of complaint and adverse event data for medical devices and pharmaceutical products.

Company Overview

The organisation provides global quality oversight and complaint management across multiple therapeutic portfolios. Teams operate within FDA and international regulatory frameworks to ensure timely evaluation of safety signals and compliance with reporting requirements. The Quality group plays a critical role in maintaining product safety, safeguarding patient wellbeing and supporting global regulatory obligations.

Job Role & Responsibilities

The Analyst oversees end-to-end complaint lifecycle management and vigilance reporting.

Core Responsibilities

• Review complaint files to determine initial triage and assess reportability per global requirements.
• Prepare and submit mandatory regulatory reports to FDA and other competent authorities.
• Gather additional clinical or product details from stakeholders to complete safety assessments.
• Escalate customer advocacy concerns and support resolution activities.
• Manage complaints from registration through follow-up, sample retrieval and closure.
• Document accurate information during customer interactions and ensure compliant communication.
• Maintain timely processing of files while adhering to regulatory reporting timelines.

Eligibility / Qualifications

Education

• Required: Graduate in Science, Medical Engineering or Allied Sciences.
• Preferred: B.Sc Nursing, Biomedical Engineering, Pharmacy, Medical Technology, Clinical Laboratory Science.

Experience & Skills

• Exposure to medical terminology and clinical use of medical or pharmaceutical products.
• Ability to analyse complaint and adverse event information with accuracy.
• Strong communication skills for coordination with internal and external parties.
• Understanding of regulated environments and quality/compliance standards.

Relevant Courses: B.Sc Life Sciences, B.Sc Nursing, Biomedical Engineering, B.Pharm, Medical Laboratory Technology, Clinical Research, Pharmaceutical Sciences.

Location & Salary

Location: Chennai, India (Hybrid mode).
Compensation will align with experience, regulatory knowledge and organisational grade. Benefits typically include medical coverage, performance-linked components and structured career progression within Quality.

Application Process

Candidates can apply directly through the official careers portal using Job ID 434.
Apply Here: https://eduu.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1/job/434
Ensure your CV highlights vigilance reporting experience, quality compliance exposure and relevant clinical or medical understanding.

EEAT Alignment

The role demands documented expertise in safety reporting, regulatory submissions and complaint evaluation. Accurate data interpretation and adherence to global reporting rules reinforce organisational credibility and trust. The content reflects the technical nature of vigilance operations and the importance of regulatory compliance.

FAQs

Q1. Is this position hybrid?
Yes. The role follows a hybrid model in Chennai.

Q2. What background is preferred?
Nursing, Biomedical Engineering, Pharmacy or Medical Technology backgrounds are preferred due to clinical relevance.

Q3. Does this role involve direct patient interaction?
No. The work focuses on complaint evaluation and regulatory reporting, not direct care.

Q4. What systems are used?
Complaint management and regulatory reporting tools; experience in FDA reporting systems is beneficial.

Q5. What does the complaint lifecycle include?
Registration, triage, information gathering, investigation, regulatory assessment and closure.

Summary Table

Category	Details
Company	Norstella
Vacancies	Analyst, GCM Vigilance Reporting
Required Education	Science/Allied Sciences, Nursing, Biomedical Engineering, Pharmacy
Experience	Experience in safety, quality or regulated healthcare environments preferred