Senior Manager Triage

About Regeneron

Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health.

As a Senior Manager, Triage Team Lead, you will lead the triage of Individual Case Safety Reports (ICSRs) within Argus Safety and oversee a team of healthcare professionals responsible for upfront medical triage activities. This role plays a critical part in ensuring accurate case assessment, regulatory compliance, and inspection-ready documentation while supporting downstream pharmacovigilance operations.

This position is office-based and will be onsite at Regeneron’s India office.

A Typical Day May Include:

• Performing medical triage of incoming ICSRs within defined timelines, including assessment of seriousness, expectedness, and causality

• Applying expedited vs. non-expedited reporting logic, including 7-day and 15-day reporting requirements

• Verifying source completeness using standardized intake checklists and identifying follow-up requirements

• Assigning cases to the appropriate Argus workflow based on reporting criteria and data completeness

• Escalating complex cases to the Lead Medical Reviewer as needed

• Authoring structured summaries for serious and high-risk cases, including patient profile, suspect product, adverse events, clinical course, causality assessment, and key review considerations

• Maintaining compliance with SOPs, data privacy standards, and inspection readiness requirements

• Developing innovative approaches to enhance operational efficiency through integration of new technologies, including AI

This Role May Be for You If You Have:

• Strong knowledge of ICH E2A, E2B, and E2D guidelines and global pharmacovigilance regulations including FDA, EMA, and Health Canada requirements

• Hands-on experience in ICSR intake, case processing, and expedited reporting workflows

• Proficiency with Argus Safety or equivalent pharmacovigilance safety databases

• Ability to interpret Reference Safety Information including IB, USPI, and SmPC documents

• Strong clinical judgment with the ability to make timely and accurate decisions under pressure

• Excellent written communication skills with the ability to prepare concise and actionable case summaries

• Familiarity with MedDRA coding practices

• Experience or interest in AI and GenAI technologies within pharmacovigilance operations

To Be Considered for This Role:

• You should have one of the following qualifications: MD / MBBS, PharmD (Doctor of Pharmacy), BDS (Bachelor of Dental Surgery), MDS (Master of Dental Surgery), or Nurse Practitioner (NP) with strong pharmacovigilance and hands-on ICSR case processing experience.

• Minimum 8+ years of total industry experience, including at least 5+ years of pharmacovigilance case processing experience

• Hands-on experience with ICSR intake, Argus Safety, and expedited reporting

• Experience handling high-volume case processing environments

• Prior experience in triage or first-line safety review activities preferred