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 opportunity to contribute to a quick-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.
- Strong clinical judgement and concise written communication under pressure.
- Triage or first-line safety review experience preferred.
- AI or generative AI experience or interest.

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📌 Senior Manager Triage (Hyderabad)
🏢 Regeneron Pharmaceuticals
📍 Hyderabad