仕事内容
About Regeneron
Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health.
As a Senior Manager, Triage Team Lead, you will lead the triage of Individual Case Safety Reports (ICSRs) within Argus Safety and oversee a team of healthcare professionals responsible for upfront medical triage activities. This role plays a critical part in ensuring accurate case assessment, regulatory compliance, and inspection-ready documentation while supporting downstream pharmacovigilance operations.
This position is office-based and will be onsite at Regeneron’s India office.
A Typical Day May Include:
Performing medical triage of incoming ICSRs within defined timelines, including assessment of seriousness, expectedness, and causality
Applying expedited vs. non-expedited reporting logic, including 7-day and 15-day reporting requirements
Verifying source completeness using standardized intake checklists and identifying follow-up requirements
Assigning cases to the appropriate Argus workflow based on reporting criteria and data completeness
Escalating complex cases to the Lead Medical Reviewer as needed
Authoring structured summaries for serious and high-risk cases, including patient profile, suspect product, adverse events, clinical course, causality assessment, and key review considerations
Maintaining compliance with SOPs, data privacy standards, and inspection readiness requirements
Developing innovative approaches to enhance operational efficiency through integration of new technologies, including AI
This Role May Be for You If You Have:
Strong knowledge of ICH E2A, E2B, and E2D guidelines and global pharmacovigilance regulations including FDA, EMA, and Health Canada requirements
Hands-on experience in ICSR intake, case processing, and expedited reporting workflows
Proficiency with Argus Safety or equivalent pharmacovigilance safety databases
Ability to interpret Reference Safety Information including IB, USPI, and SmPC documents
Strong clinical judgment with the ability to make timely and accurate decisions under pressure
Excellent written communication skills with the ability to prepare concise and actionable case summaries
Familiarity with MedDRA coding practices
Experience or interest in AI and GenAI technologies within pharmacovigilance operations
To Be Considered for This Role:
You should have one of the following qualifications: MD / MBBS, PharmD (Doctor of Pharmacy), BDS (Bachelor of Dental Surgery), MDS (Master of Dental Surgery), or Nurse Practitioner (NP) with strong pharmacovigilance and hands-on ICSR case processing experience.
Minimum 8+ years of total industry experience, including at least 5+ years of pharmacovigilance case processing experience
Hands-on experience with ICSR intake, Argus Safety, and expedited reporting
Experience handling high-volume case processing environments
Prior experience in triage or first-line safety review activities preferred
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.