Description d’emploi
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 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.