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Regeneron Pharmaceuticals

Develops biopharmaceutical therapies for serious diseases

Manager, Medical Triage

Biology & BiotechPosted on Nov 5
Full-timeHyderabad, Telangana, IndiaNo salary listedHybrid

About the Job

Requirements

  • 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.
  • 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.
  • 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.

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.

About the Company

Regeneron Pharmaceuticals

Develops biopharmaceutical therapies for serious diseases

Regeneron Pharmaceuticals develops and commercializes medicines for serious diseases, with a focus on cancer, eye diseases, allergic and inflammatory diseases, and infectious diseases. Its products come from using proprietary research capabilities and technologies to discover and develop therapies, often in collaboration with academic, research, and industry partners. Revenue comes from selling approved medicines and from licensing its technologies and entering co-development and co-commercialization partnerships. The company works with healthcare providers and regulators to ensure treatment delivery and safety. Its goal is to improve patient outcomes by bringing life-transforming medicines to market through rigorous R&D and strategic collaborations, maintaining leadership in biopharmaceutical innovation.

Company size
10,001+
Company stage
IPO
Headquarters
Town of Mount Pleasant, New York
Founded
1988

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