Build our future together:
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director to join our Global Patient Safety POD, supporting our global programmes in a hybrid role. In this role, you will lead end-to-end ICSR triage and medical review while collaborating with global safety and clinical development teams. This position offers the chance to contribute to a fast-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:
- Oversee Individual Case Safety Report medical review and accurate data capture in Argus.
- Lead triage harmonisation and end-to-end case quality across the India POD.
- Review narratives, author analyses, causality rationale, and reporting decisions.
- Guide expectedness determinations against programmes, products, and approved labelling.
- Oversee clinically appropriate MedDRA coding for adverse events and medical history.




- Partner with pharmacovigilance, risk management, and clinical teams before regulatory submissions.
- Support compounds, case issue resolution, SOP development, process improvements, and inspection readiness.
- You explore artificial intelligence technologies to strengthen pharmacovigilance activities.

This role requires:
- MD or MBBS with active Indian registration or eligibility.
- 10+ years’ industry experience, including 7+ years in pharmacovigilance.
- Hands-on ICSR review, narrative authoring, causality assessment, expectedness determination, and MedDRA coding.
- Expert knowledge of ICH E2A, E2B, E2D, and FDA/EMA pharmacovigilance regulations.
- Proficiency with Argus Safety or equivalent safety databases.
- Strong clinical judgement and clear written rationale.
- Global development or marketed product experience preferred.
- GPS POD or insourced pharmacovigilance experience is advantageous.

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📌 Associate Director, Triage and Medical Review (Hyderabad)
🏢 Regeneron Pharmaceuticals
📍 Hyderabad