Manager Triage

Regeneron Pharmaceuticals; Hyderabad; Presencial; INR 1.500.000 - 2.100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Descripción de la vacante

Regeneron Pharmaceuticals in Hyderabad is seeking a Manager, Medical Triage to act as the first medical contact for ICSR intake and guide cases into regulatory workflows. You will exercise medical judgement to assess seriousness, expectedness, and causality, and ensure timely reporting.

You will apply 7/15-day timelines, verify data completeness, and draft concise preliminary summaries for high-risk cases. The role emphasizes process improvements and inspection readiness, with AI-enabled

Formación

• This role requires MD/MBBS/PharmD/BDS/MDS or NP with active registration.
• 7–9 years of pharmacovigilance case-processing experience, including ICSR intake and expedited reporting.
• Strong knowledge of ICH E2A, E2B, E2D guidelines and FDA/EMA/Health Canada requirements.
• Experience with Oracle Argus Safety or equivalent safety database.
• Clear, concise written communication and attention to detail in triage decisions.

Responsabilidades

• Perform first-pass medical review of ICSRs within defined timelines and assess seriousness, expectedness, and causality.
• Make independent 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; prioritize cases with active reporting clocks.
• Verify source completeness using standardized intake criteria and flag missing information for follow-up.
• Route cases to appropriate safety workflow and escalate when needed.
• Draft concise preliminary case summaries for serious and high-risk cases.
• Monitor triage quality indicators and contribute to process improvements.
• Support SOP compliance, data privacy, audit responses, and use of AI tools.

Conocimientos

Pharmacovigilance

ICSR intake

Regulatory knowledge

Oracle Argus

AI awareness

Educación

MD/MBBS/PharmD

Nurse Practitioner

Herramientas

Oracle Argus Safety

Descripción del empleo

Manager, Medical Triage

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.

Location

Hyderabad

Responsibilities

• 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.

Requirements

• 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.

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
• 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.

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.

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.

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.