Job Description
Build our future together:
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager to join our safety team, supporting our operations in a hybrid role. In this role, you will lead Individual Case Safety Report triage while collaborating with healthcare professionals and medical reviewers. This position offers the prospect to contribute to a rapid-growing, science-driven organization making a meaningful difference to patients worldwide.

When & Where
Hyderabad, India (Hybrid - three days a week on site)

Discover Your Role
Lead healthcare professionals performing upfront medical triage in Argus Safety.
Assess seriousness, expectedness, causality, and reporting timelines for incoming cases.
Apply expedited reporting logic, including seven-day and 15-day requirements.
Verify source completeness, identify follow-up needs, and assign Argus workflows.
Escalate complex cases to the Lead Medical Reviewer.
Author structured summaries covering clinical course, causality,



and review considerations.
Maintain SOP, data privacy, documentation, and inspection readiness standards.
You explore artificial intelligence technologies to improve operational efficiency.

This Role Requires
MD, MBBS, PharmD, BDS, MDS, or Nurse Practitioner qualification.
8+ years’ industry experience, including 5+ years in pharmacovigilance case processing.
Hands-on ICSR intake, Argus Safety, and expedited reporting experience.
Knowledge of ICH E2A, E2B, E2D, FDA, EMA, and Health Canada requirements.
Ability to interpret Investigator’s Brochures, US Prescribing Information, and Summaries of Product Characteristics.
MedDRA coding familiarity and high-volume case processing experience.
Solid clinical judgement and concise written communication under pressure.
Triage or first-line safety review experience preferred.
AI or generative AI experience or interest.

Does this

📌 Senior Manager Triage Hyderabad
🏢 Bioksha
📍 Hyderabad