Pharmacovigilance Job at Regeneron, Hyderabad
Looking to take the next step in your Pharmacovigilance career with a global biotechnology leader? Regeneron is hiring a Senior Manager – Triage Team Lead for its Hyderabad office. This Pharmacovigilance Job in Hyderabad is an excellent opportunity for experienced pharmacovigilance professionals with expertise in Individual Case Safety Reports (ICSRs), Argus Safety, and global safety regulations. If you have strong clinical judgment, leadership skills, and a passion for ensuring patient safety, this position at Regenreon Careers offers an exciting opportunity to contribute to global drug safety operations.
About the Company:
Regeneron is a leading global biotechnology company committed to inventing, developing, and commercializing life-changing medicines for people with serious diseases. Driven by scientific innovation and cutting-edge research, Regeneron has transformed healthcare through breakthrough therapies across multiple therapeutic areas. The company fosters a collaborative and inclusive work environment, empowering employees to make meaningful contributions to global health while advancing innovation in drug development and pharmacovigilance.
Job Details:
- Job Title: Senior Manager – Triage Team Lead
- Job ID: R47759
- Department: Global Development
- Location: Hyderabad, Telangana, India
- Employment Type: Full-Time
- Work Mode: Office-Based (Onsite)
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 is required for this Pharmacovigilance Job in Hyderabad.
- 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 Pharmacovigilance Job:
- 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
