We are a globally recognized leader in the pharmaceutical and medical device industry, committed to improving patient care through innovation and compliance. Our vigilance and quality assurance teams play a crucial role in ensuring product safety and regulatory adherence worldwide.
Position Summary
We are hiring an Analyst, GCM Vigilance Reporting to manage pharmaceutical and medical device complaints and adverse events on a global scale. The role involves:
- Initial triage of complaint files
- Assessing reportability per regulatory guidelines
- Submitting regulatory reports to the FDA and other authorities
- Escalating critical customer advocacy cases
- Ensuring timely processing of complaints
This is a hybrid role based in Chennai, offering a dynamic work environment with opportunities for professional growth.
Key Responsibilities
✔ Evaluate complaints from a patient safety perspective and determine regulatory reporting requirements.
✔ Prepare and submit regulatory reports to the FDA and global health authorities.
✔ Gather additional event details through follow-ups with customers and healthcare professionals.
✔ Escalate customer advocacy issues and assist in resolution.
✔ Manage complaint lifecycle—registration, investigation, sample retrieval, and closure.
✔ Provide accurate and timely responses to customers (verbal/written).
Skills & Qualifications
🔹 Preferred Background:
- Bachelor’s degree in Nursing, Bio-Medical Engineering, Pharmacy, or Medical Technology.
- Experience in healthcare, pharmacovigilance, or FDA-regulated industries.
🔹 Required Skills:
- Knowledge of medical terminology and pharmaceutical/device usage.
- Strong communication skills for internal/external interactions.
- Ability to analyze complaints and adverse events efficiently.
Why Join Us?
✅ Work with a global leader in healthcare compliance.
✅ Hybrid work model for better work-life balance.
✅ Opportunities for career advancement in pharmacovigilance and regulatory affairs.
How to Apply
Suggested for:
- PV associates looking to expand into medical device vigilance.
- Professionals in regulatory affairs & compliance seeking crossover into safety reporting.
