Are you looking to build a strong career in vigilance reporting, pharmacovigilance, or medical device complaint handling? This Analyst opportunity in Chennai offers the perfect platform for professionals interested in global device complaint management, regulatory reporting, and patient safety compliance.
This role is ideal for candidates with a science or pharmacy background looking to advance in a global quality, safety, or regulatory role.
🔍 Role Overview
As an Analyst, GCM Vigilance Reporting, you will manage global complaints and vigilance reporting for pharmaceutical or medical device products. Your work will directly support regulatory compliance, patient safety, and timely submission of reportable events to regulatory authorities such as the FDA and regional competent authorities.
📌 Key Responsibilities
- Perform complaint triage and evaluate cases from a patient safety perspective.
- Make global regulatory reporting decisions based on applicable standards.
- Create and submit regulatory reports to authorities (e.g., FDA, EU Competent Authorities).
- Manage complaints throughout lifecycle: registration → investigation → closure.
- Collect, assess, and interpret complaint and adverse event information.
- Coordinate follow-ups for incomplete case data and ensure timely report updates.
- Escalate customer advocacy issues when necessary and support resolution.
- Communicate effectively with internal teams and external stakeholders.
🧠 Required Skills & Knowledge
- Strong understanding of medical terminology, clinical product usage, and patient safety concepts.
- Ability to analyze safety data, risk signals, and complaint information.
- Excellent written and verbal communication for regulatory and customer communication.
- Knowledge of FDA, EU MDR, vigilance reporting processes, ICSR handling, and QMS environments is preferred.
🎓 Education & Experience
✔ Required:
- Graduate in Science, Medical Engineering, or Allied Sciences
✔ Preferred:
- B.Sc Nursing, Pharmacy, Biomedical Engineering, Medical Technology, or Clinical Laboratory Science
- Experience in healthcare, quality assurance, medical devices, or regulatory reporting
💼 Benefits of Joining
- Hybrid working model
- Exposure to global regulatory and vigilance frameworks
- Career growth in Quality, Regulatory Affairs, and Pharmacovigilance
- Opportunity to work in a compliance-driven, FDA-regulated environment
