Pharmacovigilance Job at Regeneron, Hyderabad
Looking for a senior pharmacovigilance leadership role in the biopharma industry? Regeneron is hiring a Senior Manager – Triage Team Lead for its India office. This Pharmacovigilance Job in Hyderabad is ideal for experienced healthcare professionals with expertise in ICSR processing, drug safety operations, and global pharmacovigilance regulations. Candidates with MBBS, MD, PharmD, BDS, MDS, or Nurse Practitioner qualifications and strong hands-on safety database experience can apply. The role at Regeneron Careers offers exposure to global safety operations, AI-driven pharmacovigilance innovation, and leadership responsibilities within a leading biotechnology organization.
About the Company:
Regeneron is a globally recognized biotechnology company focused on inventing, developing, and commercializing life-changing medicines for serious diseases. The company is known for its innovative research approaches in science, healthcare, manufacturing, and drug development. Regeneron operates with a strong commitment to improving patient outcomes through cutting-edge therapeutics and advanced healthcare technologies across multiple therapeutic areas worldwide.
Job Details:
- Job Role: Senior Manager – Triage Team Lead
- Industry: Biotechnology / Pharmacovigilance / Drug Safety
- Work Mode: Office-Based
- Job Location: India Office
- Department: Pharmacovigilance & Drug Safety
Key Responsibilities:
- Lead medical triage of incoming Individual Case Safety Reports (ICSRs)
- Assess the seriousness, expectedness, and causality of adverse events
- Apply expedited and non-expedited reporting logic, including 7-day and 15-day reporting requirements
- Verify source completeness and identify follow-up requirements using intake checklists
- Assign cases to appropriate Argus Safety workflows in this Pharmacovigilance Job in Hyderabad
- Escalate complex safety cases to Lead Medical Reviewers when required
- Prepare structured summaries for serious and high-risk cases
- Maintain compliance with SOPs, regulatory requirements, and inspection readiness standards at Regeneron Careers
- Support operational efficiency through AI and GenAI technology integration
- Collaborate with downstream pharmacovigilance teams and safety operations
- Ensure accurate documentation and regulatory-compliant safety reporting
- Participate in process improvements and pharmacovigilance quality initiatives
Educational Requirements for this Pharmacovigilance Job:
Essential Qualification:
- MD
- MBBS
- PharmD
- BDS
- MDS
Required Experience:
- Minimum 8+ years of industry experience
- At least 5+ years in pharmacovigilance case processing
Preferred Experience:
- Triage or first-line safety review activities
- Handling high-volume safety case processing environments
- Hands-on Argus Safety database experience
Skills Required:
- Strong knowledge of ICH E2A, E2B, and E2D guidelines
- Understanding of global pharmacovigilance regulations including FDA, EMA, and Health Canada requirements
- Expertise in ICSR intake and expedited reporting workflows
- Proficiency in Argus Safety and pharmacovigilance databases
- Ability to interpret Reference Safety Information including IB, USPI, and SmPC documents
- Strong clinical judgment and medical decision-making skills
- Excellent written communication and case summary preparation abilities
- Familiarity with MedDRA coding practices
- Ability to work under pressure in high-volume safety environments
- Knowledge of SOPs, data privacy standards, and inspection readiness requirements
- Interest or experience in AI and GenAI technologies in pharmacovigilance operations
- Leadership and team coordination capabilities
Benefits of the Pharmacovigilance Job:
- Opportunity to work with a globally renowned biotechnology company
- Leadership role in global pharmacovigilance and drug safety operations
- Exposure to advanced AI and GenAI technologies in healthcare
- Hands-on experience in global regulatory safety reporting
- Career growth in medical safety and pharmacovigilance leadership
- Work on innovative therapies and life-changing medicines
- Collaborative work environment with international healthcare experts
- Opportunity to develop expertise in global safety surveillance systems
- Exposure to regulatory inspections and high-level safety review activities
- Inclusive workplace culture with employee-focused benefits and growth opportunities
