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Case Management – Specialist (Device Safety)

4-9 years
Not Disclosed
10 Feb. 5, 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

Job Title: Case Management – Specialist (Device Safety)
Location: India - Hyderabad
Category: Medical Services
Job ID: R-205444


About Amgen

Amgen is a global biotech leader focused on transforming the lives of patients living with serious illnesses. Since 1980, Amgen has pioneered the fight against tough diseases in oncology, inflammation, general medicine, and rare diseases, making a meaningful impact on millions of lives. Join the Amgen team and become part of their mission to help people live longer, fuller lives.


Key Responsibilities

  • Case Management: Ensure the quality of device/combination product Individual Case Safety Reports (ICSR) globally, from clinical trials to post-market cases.
  • Vendor Oversight: Manage vendor relationships to ensure compliance with case intake, processing activities, and quality standards.
  • Regulatory Reporting: Submit individual case safety reports to regulatory bodies (FDA/EMA) and license partners.
  • Audit Support: Provide audit and inspection support for case management activities, ensuring adherence to pharmacovigilance practices.
  • Collaboration & Training: Collaborate with vendors to provide resources, training, and support to meet regulatory requirements.
  • Continuous Improvement: Contribute to the implementation of new systems and procedures to enhance case management processes.

Qualifications

  • Basic Qualifications:
    • Doctorate degree with 4 years of Drug Safety or Life Sciences experience OR
    • Master’s degree with 7 years of Drug Safety or Life Sciences experience OR
    • Bachelor’s degree with 9 years of Drug Safety or Life Sciences experience.
  • Preferred Qualifications:
    • Experience in pharmacovigilance or quality in biotech, pharmaceutical, or medical device industries.
    • Familiarity with clinical development processes and global regulatory requirements (GMP, GxP).
    • Previous experience with safety databases and corporate intake systems.
    • Strong analytical skills, attention to detail, and experience working with project management tools.

Skills & Knowledge

  • Understanding of global regulatory requirements for pharmacovigilance and Good Manufacturing Practices.
  • Ability to manage case processing quality and provide support across cross-functional teams.
  • Proficiency in Microsoft Suite (Word, Excel, PowerPoint, Project, Outlook).

Benefits & Culture

Amgen offers a competitive total rewards package, including base salary and additional benefits, alongside a collaborative and inclusive work culture that encourages growth and development. Amgen is committed to advancing science and improving patient care, and the company values a diverse and ethical workforce.