Want to know if this job is worth applying to?
Hyderabad, Telangana, India
Hybrid
Build our future together:
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager to join our safety team, supporting our operations in a hybrid role. In this role, you will lead Individual Case Safety Report triage while collaborating with healthcare professionals and medical reviewers. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Hyderabad, India (Hybrid - three days a week on site)
Lead healthcare professionals performing upfront medical triage in Argus Safety.
Assess seriousness, expectedness, causality, and reporting timelines for incoming cases.
Apply expedited reporting logic, including seven-day and 15-day requirements.
Verify source completeness, identify follow-up needs, and assign Argus workflows.
Escalate complex cases to the Lead Medical Reviewer.
Author structured summaries covering clinical course, causality, and review considerations.
Maintain SOP, data privacy, documentation, and inspection readiness standards.
You explore artificial intelligence technologies to improve operational efficiency.
MD, MBBS, PharmD, BDS, MDS, or Nurse Practitioner qualification.
8+ years’ industry experience, including 5+ years in pharmacovigilance case processing.
Hands-on ICSR intake, Argus Safety, and expedited reporting experience.
Knowledge of ICH E2A, E2B, E2D, FDA, EMA, and Health Canada requirements.
Ability to interpret Investigator’s Brochures, US Prescribing Information, and Summaries of Product Characteristics.
MedDRA coding familiarity and high-volume case processing experience.
Strong clinical judgement and concise written communication under pressure.
Triage or first-line safety review experience preferred.
AI or generative AI experience or interest.
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.