A leading FDA-regulated global healthcare organization is hiring for the position of Analyst – GCM Vigilance Reporting in Chennai, India (Hybrid). This role is ideal for candidates from pharmacy, biomedical, nursing, life sciences, and allied health backgrounds who are seeking a career in pharmacovigilance, medical device vigilance, and regulatory reporting.
The position focuses on global complaint handling, adverse event evaluation, and regulatory submissions in compliance with international safety reporting requirements.
Key Responsibilities – Analyst GCM Vigilance Reporting
- Perform initial triage of medical device and pharmaceutical complaints
- Evaluate complaints from a patient safety and vigilance perspective
- Assess global reportability as per FDA and regional competent authority regulations
- Prepare and submit regulatory reports (FDA, global authorities)
- Escalate customer advocacy and safety-critical events
- Collect additional follow-up information related to adverse events
- Manage complaint lifecycle including registration, investigation, follow-up, and closure
- Coordinate with internal quality, regulatory, and safety teams
- Provide accurate verbal and written communication to customers and stakeholders
- Ensure timely processing of complaints as per compliance timelines
Primary Keywords Used:
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Long-Tail Keywords Used:
Global complaint handling jobs, FDA regulatory reporting analyst, hybrid pharmacovigilance jobs India
Eligibility Criteria & Qualifications
Required Qualification
- Graduate degree in:
- Science
- Medical Engineering
- Allied Health Sciences
Preferred Qualification
- Bachelor’s degree in:
- Pharmacy
- Nursing
- Biomedical Engineering
- Medical Technology / Clinical Laboratory Science
- Experience in:
- Healthcare environment
- Quality, compliance, regulatory, or vigilance roles
- FDA-regulated pharmaceutical or medical device organizations
Skills Required
- Strong knowledge of medical terminology
- Understanding of clinical use of medical/pharmaceutical products
- Ability to analyze and interpret adverse event data
- Excellent communication and documentation skills
- Regulatory mindset with attention to detail
Why Apply for This Role?
- Work in a global pharmacovigilance and market surveillance team
- Exposure to international regulatory reporting
- Hybrid work model (Chennai)
- Strong career growth in drug safety & medical device vigilance
- Opportunity to work in a quality-driven, FDA-regulated environment
Salary Package (Estimated)
- ₹6,00,000 – ₹10,00,000 per annum
(Salary may vary based on experience, skills, and internal benchmarks)
