Medical Reviewer Job at Regeneron, Hyderabad
Want to advance your career in Pharmacovigilance and Drug Safety leadership? Regeneron is hiring an Associate Director, Triage and Medical Review for its Hyderabad office. This role is ideal for experienced MBBS/MD professionals with strong expertise in ICSR medical review, pharmacovigilance operations, and global safety regulations. Candidates will lead triage and medical review activities for global development programs and marketed products while ensuring compliance with international PV standards. This Medical Reviewer Job at Regeneron Careers in Hyderabad is an excellent opportunity to work on advanced drug safety operations and AI-driven pharmacovigilance initiatives.
About the Company:
Regeneron is a leading biotechnology company focused on inventing, developing, and commercializing life-changing medicines for serious diseases. The company is known for its innovation in science, manufacturing, and healthcare research. Regeneron operates globally with a strong commitment to improving patient outcomes through advanced therapeutic solutions and pioneering healthcare technologies.
Job Details:
- Job Title: Associate Director, Triage and Medical Review
- Job ID: R47768
- Location: Hyderabad
- Department: Global Development – Global Patient Safety (GPS)
- Employment Type: Full Time
- Work Mode: On-Site/Office Based
- Qualification Required: MBBS/MD
- Experience Required: 10+ Years Total Industry Experience
- Pharmacovigilance Experience: Minimum 7+ Years
- Industry: Biotechnology & Pharmacovigilance
Key Responsibilities:
- Oversee complete medical review of Individual Case Safety Reports (ICSRs)
- Ensure medically relevant information is accurately documented in Argus in this Medical Reviewer Job
- Lead triage and medical review teams for harmonized safety operations
- Review narratives, author analyses, causality rationale, and reporting decisions
- Provide oversight on expectedness determinations and MedDRA coding at Regeneron Careers
- Collaborate with PV teams, clinical development teams, and regulatory stakeholders
- Support SOP development and process improvement initiatives in this Job in Hyderabad
- Ensure inspection readiness and compliance with global PV standards
- Serve as a medical resource for assigned Regeneron compounds
- Explore and implement AI technologies within pharmacovigilance operations
Educational Requirements for this Medical Reviewer Job:
- An MBBS or an MD degree is mandatory
- Active registration or eligibility for registration with the Indian medical regulatory body is required
- Strong pharmacovigilance and medical review experience preferred
- Experience with global development programs or marketed products is an advantage
Skills Required:
- Strong expertise in ICSR medical review
- Knowledge of ICH E2A, E2B, E2D guidelines
- Understanding of FDA and EMA pharmacovigilance regulations
- Proficiency in Argus Safety or equivalent databases
- Advanced MedDRA coding expertise
- Strong clinical judgment and analytical skills
- Medical writing and documentation abilities
- Leadership and stakeholder management skills
- Interest in AI applications within pharmacovigilance
- Excellent communication and collaboration abilities
Benefits of the Medical Reviewer Job:
- Opportunity to work with a globally recognized biotechnology company
- Exposure to advanced global pharmacovigilance operations
- Leadership role in drug safety and medical review
- Opportunity to work on AI-driven PV initiatives
- Career growth in global patient safety and regulatory operations
- Collaborative and innovation-focused work environment
- Access to employee wellness and professional development programs
