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Senior Manager Global Safety

14-18 years
Not Disclosed
10 Jan. 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Manager Global Safety
Location: India - Hyderabad
Work Location Type: On Site
Posted: Jan. 13, 2025

Join Amgen’s Mission of Serving Patients
At Amgen, our mission is to serve patients living with serious illnesses. Since 1980, we’ve pioneered advancements in biotech to address the world’s toughest diseases. Focused on Oncology, Inflammation, General Medicine, and Rare Disease, our team impacts millions of lives. Be part of Amgen’s collaborative, innovative culture and transform lives—including your own.

Senior Manager Global Safety

What You Will Do
In this vital role, you will provide medical review of Individual Case Safety Reports (ICSRs) to support safety surveillance for Amgen products and ensure compliance with global regulatory reporting requirements. You will supervise a team of 1-10 staff and act as a critical point of contact for medical safety operations.

Key responsibilities include:

  • Conducting detailed medical review of ICSRs, ensuring accuracy in narratives, coding, expectedness, causality, and seriousness.
  • Acting as a key contact between Case Management and Global Safety Officers (GSOs) on medical content and reporting.
  • Leading MSRT (Medical Safety Review Team) product activities and ensuring ICSR quality.
  • Monitoring compliance with auto label tools and overseeing updates.
  • Mentoring junior medical reviewers and providing training for internal teams and vendors.
  • Supporting cross-functional initiatives, including process improvements, SOP creation, and metrics development.
  • Maintaining inspection readiness and representing Amgen during audits or Health Authority inspections.

Basic Qualifications

  • Doctorate degree with 2 years of relevant experience OR
  • Master’s degree with 8-10 years of relevant experience OR
  • Bachelor’s degree with 10-14 years of relevant experience OR
  • Diploma with 14-18 years of relevant experience

What You Can Expect of Us
We prioritize your professional and personal growth, offering competitive benefits and a supportive culture. Join us for a career that transforms lives and defies imagination.

Apply Now
Be part of an organization committed to ethical, diverse, and inclusive values, advancing science to serve patients.