03 Oct
|
Regeneron Pharmaceuticals
|
Hyderabad
03 Oct
Regeneron Pharmaceuticals
Hyderabad
Build our future together:
At Regeneron, we use science and innovation to develop life-changing medicines for people with responsible 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 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:
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