Corporate Healthcare Job at Regeneron
Are you ready to take on a leadership role in pharmacovigilance? As a Senior Manager at Regeneron, you will oversee the triage of Individual Case Safety Reports, ensuring that safety assessments are conducted efficiently and accurately. This Corporate Healthcare Job is pivotal in safeguarding patient health and advancing our mission to deliver transformative medicines. You will have the chance to work with a dedicated team of professionals, utilising your expertise to make a tangible impact on global healthcare. Join us in this dynamic environment where your skills in medical safety can truly shine.
About Regeneron:
Regeneron is a leading biotechnology company that uses science and innovation to develop life-changing medicines for serious diseases. With a commitment to transforming the lives of patients, Regeneron operates globally and is recognised for its cutting-edge research and development in the pharmaceutical sector.
Job Details:
- Designation: Senior Manager Triage
- Location: Hyderabad, Telangāna, India
- Department: Global Development
- Reference Number: R47759
Job Description:
At Regeneron, the Senior Manager 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.
Key Responsibilities:
- 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.
- Explore artificial intelligence technologies to improve operational efficiency.
Eligibility Criteria for the Corporate Healthcare Job:
- MD, MBBS, PharmD, BDS, MDS, or a related field.
- 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.
