Medical Reviewer Job at Regeneron, Hyderabad
Ready to lead pharmacovigilance medical review activities for a global biotechnology company? Regeneron is hiring a Senior Manager, Pharmacovigilance Medical Review, to join its Global Patient Safety team in Hyderabad. This Medical Reviewer Job in Hyderabad offers experienced medical professionals an opportunity to contribute to global drug safety programs, ensuring high-quality safety assessments for both development-stage and marketed products. The position at Regeneron Careers involves medical review of Individual Case Safety Reports (ICSRs), causality assessments, narrative writing, and collaboration with global pharmacovigilance teams. Candidates with strong pharmacovigilance expertise and clinical judgment will play a critical role in maintaining regulatory compliance and patient safety. This is an excellent opportunity to work in a science-driven organization dedicated to developing life-changing medicines.
About the Company:
Regeneron is a leading global biotechnology company focused on discovering, developing, and commercializing innovative medicines for serious diseases. Through cutting-edge science and advanced research capabilities, Regeneron develops therapies that address unmet medical needs across multiple therapeutic areas. The company is recognized globally for its commitment to scientific excellence, patient-centered innovation, and impactful healthcare solutions. With a strong focus on research, technology, and collaboration, Regeneron continues to transform patient care worldwide.
Job Details:
- Job Title: Senior Manager, Pharmacovigilance Medical Review
- Department: Global Patient Safety
- Job Location: Hyderabad, Telangana, India
- Work Mode: Hybrid
- Job Category: Global Development
- Job ID: R47767
- Employment Type: Full-Time
- Industry: Biotechnology and Pharmacovigilance
- Experience Required: 8–10 Years
- Preferred Domain: Drug Safety and Pharmacovigilance
Key Responsibilities:
- Lead end-to-end medical review of safety cases.
- Perform and oversee medical review of Individual Case Safety Reports (ICSRs).
- Ensure scientific accuracy and regulatory compliance of safety reports.
- Author and review case narratives and company causality assessments.
- Conduct analysis of similar events and expectedness evaluations.
- Code adverse events and medical history using MedDRA.
- Collaborate with pharmacovigilance, risk management, triage, and clinical development teams in this Medical Reviewer Job in Hyderabad.
- Support inspection-ready documentation for regulatory submissions.
- Act as a medical resource for assigned products and compounds.
- Resolve complex safety case issues and provide expert guidance at Regeneron Careers.
- Drive process improvements and SOP development initiatives.
- Support implementation of innovative technologies, including AI-driven solutions.
- Mentor managers and junior reviewers on medical and regulatory standards.
Educational Requirements for the Medical Reviewer Job:
Essential Qualification
- MBBS or MD degree.
- Active registration or eligibility for registration with the relevant Indian Medical Council or professional regulatory body.
Preferred Qualification
- Advanced expertise in pharmacovigilance and drug safety.
- Experience supporting global development programs or marketing products.
Experience Requirement for the Medical Reviewer Job:
- Minimum 8–10 years of pharmacovigilance experience.
- Hands-on experience in ICSR medical review.
- Experience in narrative writing and causality assessment.
- Expertise in expectedness determination and regulatory safety reporting.
Skills Required:
Pharmacovigilance Skills
- Strong knowledge of Individual Case Safety Report (ICSR) review.
- Expertise in adverse event assessment and signal evaluation.
- Experience in narrative authoring and safety data analysis.
- Knowledge of global drug safety practices.
Regulatory Knowledge
- Strong understanding of ICH E2A, E2B, and E2D guidelines.
- Familiarity with FDA and EMA pharmacovigilance regulations.
- Knowledge of global safety reporting requirements.
Technical Skills
- Proficiency in Argus Safety or equivalent pharmacovigilance databases.
- Expertise in MedDRA coding.
- Experience with safety data management systems.
- Familiarity with AI or Generative AI tools in pharmacovigilance is advantageous.
Leadership and Communication Skills
- Strong clinical judgment and decision-making abilities.
- Excellent scientific writing and communication skills.
- Ability to mentor and guide team members.
- Strong stakeholder management and cross-functional collaboration skills.
- Problem-solving and process improvement capabilities.
Benefits of the Medical Reviewer Job:
- Opportunity to work with a globally renowned biotechnology company.
- Leadership role within an international pharmacovigilance team.
- Exposure to global drug development and marketed product safety programs.
- Opportunity to collaborate with experts across India, the US, and Europe.
- Career advancement in drug safety and medical review leadership.
- Experience working with innovative technologies and AI-driven solutions.
- Comprehensive employee benefits and wellness programs.
- Performance-based rewards and professional development opportunities.
- Inclusive and collaborative work culture.
- Opportunity to contribute directly to patient safety and life-changing therapies worldwide.
