Manager Triage

Regeneron; Telangana; Presencial; INR 1.800.000 - 2.400.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. in Hyderabad seeks a Manager, Medical Triage within Global Patient Safety.

You will serve as the first medical contact for Individual Case Safety Reports and guide cases into the correct regulatory workflow. You will make decisions on seriousness, expectedness, causality, and reporting timelines, perform first-pass medical review, and draft concise preliminary case summaries for high-risk cases.

Formación

• MD/MBBS/PharmD/BDS/MDS or NP with active registration in India.
• 7–9 years of pharmacovigilance case-processing experience.
• Strong knowledge of ICH guidelines and regulatory requirements.
• Experience with safety databases, preferably Oracle Argus Safety.
• Exposure to AI tools in pharmacovigilance.

Responsabilidades

• Perform first-pass medical review of incoming Individual Case Safety Reports within defined timelines and assess seriousness, expectedness, and causality.
• Make independent medical triage decisions for routine, complex, and ambiguous cases while maintaining regulatory reporting compliance.
• Apply expedited and non-expedited reporting logic, including 7-day and 15-day timelines, and prioritize cases with active reporting clocks.
• Verify source completeness using standardized intake criteria and flag missing or insufficient information for follow-up.
• Route cases to the appropriate safety workflow based on medical assessment, reporting status, and data completeness, escalating when needed.
• Author concise preliminary case summaries for serious and high-risk cases to support downstream processing and regulatory submission.
• Monitor triage quality indicators, including classification accuracy and rework rates, and contribute to corrective actions and process improvements.
• Support SOP compliance, data privacy, inspection readiness, audit responses, and innovative approaches using new technologies, including AI.

Conocimientos

First-pass medical review

Independent medical triage

Regulatory compliance

Clear written communication

Educación

MD / MBBS / PharmD / BDS / MDS / NP

Herramientas

Oracle Argus Safety

Descripción del empleo

Build our future together

At Regeneron, Global Patient Safety helps protect patients by ensuring every incoming safety report receives timely, accurate, and scientifically sound medical assessment. As Manager, Medical Triage, you will serve as the first medical point of contact for Individual Case Safety Reports and guide cases into the correct regulatory workflow. Your decisions on seriousness, expectedness, causality, reporting timelines, and data completeness will help prioritize high-risk cases, reduce downstream rework, and support inspection-ready documentation. Working across globally connected safety teams, you will combine rapid clinical judgement with clear communication and help improve triage processes through quality metrics, innovation, and responsible use of new technologies, including AI.

Build our future together

At Regeneron, Global Patient Safety helps protect patients by ensuring every incoming safety report receives timely, accurate, and scientifically sound medical assessment. As Manager, Medical Triage, you will serve as the first medical point of contact for Individual Case Safety Reports and guide cases into the correct regulatory workflow. Your decisions on seriousness, expectedness, causality, reporting timelines, and data completeness will help prioritize high-risk cases, reduce downstream rework, and support inspection-ready documentation. Working across globally connected safety teams, you will combine rapid clinical judgement with clear communication and help improve triage processes through quality metrics, innovation, and responsible use of new technologies, including AI.

When & where

Location: Hyderabad

Discover your role

• Perform first-pass medical review of incoming Individual Case Safety Reports within defined timelines and assess seriousness, expectedness, and causality.
• Make independent medical triage decisions for routine, complex, and ambiguous cases while maintaining regulatory reporting compliance.
• Apply expedited and non-expedited reporting logic, including 7-day and 15-day timelines, and prioritize cases with active reporting clocks.
• Verify source completeness using standardized intake criteria and flag missing or insufficient information for follow-up.
• Route cases to the appropriate safety workflow based on medical assessment, reporting status, and data completeness, escalating when needed.
• Author concise preliminary case summaries for serious and high-risk cases to support downstream processing and regulatory submission.
• Monitor triage quality indicators, including classification accuracy and rework rates, and contribute to corrective actions and process improvements.
• Support SOP compliance, data privacy, inspection readiness, audit responses, and innovative approaches using new technologies, including AI.

This role requires

• An MD, MBBS, PharmD, BDS, MDS, or Nurse Practitioner qualification, with active registration or eligibility for registration with the relevant Indian professional regulatory body.
• 7-9 years of pharmacovigilance case-processing experience, including direct exposure to ICSR intake, first-line safety review, and expedited reporting.
• Strong knowledge of ICH E2A, E2B, and E2D guidelines and relevant FDA, EMA, and Health Canada pharmacovigilance requirements.
• Demonstrated ability to interpret Reference Safety Information, including investigator brochures, US prescribing information, and summaries of product characteristics.
• Proficiency with Oracle Argus Safety or an equivalent safety database, with rapid and well-reasoned clinical judgement under time pressure.
• Clear, concise written communication and strong attention to detail when documenting triage decisions and preliminary case summaries.
• Experience supporting high-volume case processing or a dedicated medical triage or first-line safety review function.
• Familiarity with MedDRA terminology and its application in pharmacovigilance case assessment.
• Exposure to AI or generative AI tools in pharmacovigilance, safety operations, or clinical documentation.

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.