Baxter is a trusted leader in providing life-saving medical products and therapies found in hospitals, clinics, and homes worldwide. Our collaborative environment fosters innovation, teamwork, and a strong sense of purpose. By joining Baxter, you become part of a team dedicated to enhancing patient safety and delivering excellence in healthcare.
Role Overview: Medical Reviewer
Location: Gurgaon / Ahmedabad
As a Medical Reviewer, you will play a crucial role in ensuring patient safety by reviewing and assessing adverse event case reports, contributing to regulatory compliance, and maintaining global safety standards.
Key Responsibilities
- Adverse Event Case Review:
- Medical review of individual case safety reports, including coding, seriousness, expectedness, and causality assessments.
- Regulatory Expertise:
- Provide medical and scientific insights on pharmacovigilance for accurate and timely submissions to regulatory authorities like FDA and EMA.
- Safety Team Support:
- Guide the Safety Operations team on case processing, medical coding conventions, and interpretation.
- Safety Surveillance:
- Perform benefit-risk analysis and safety surveillance for signals and review aggregate safety data.
- Documentation:
- Contribute to safety-related documents like PSURs, PBRERs, PADERs, and risk management plans.
Qualifications
Educational Requirements:
- Medical degree (or equivalent) with board certification/eligibility.
Experience:
- Minimum of 2 years of post-residency experience, with at least 1 year in the pharmaceutical or biotechnology industry.
- Exposure to FDA, EMA, or other regulatory bodies preferred.
Skills and Knowledge:
- Strong understanding of global drug safety regulations and adverse event case triage processing.
- Familiarity with safety coding systems like MedDRA and WHOART.
- Excellent communication, teamwork, and presentation skills.
