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Pc Triage And Intake Associate

5+ 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: PC Triage and Intake Associate
Location: India - Hyderabad
Category: Medical Services
Job ID: R-205446


About Amgen

Amgen is a leading biotech company focused on serving patients with serious illnesses. Since 1980, Amgen has been at the forefront of pioneering treatments for oncology, inflammation, general medicine, and rare diseases, impacting millions of lives. By joining Amgen, you’ll be part of a team dedicated to advancing science and improving patient outcomes.


Key Responsibilities

  • Triage and Intake: Responsible for triaging product complaints (PCs), adverse events (AEs), and other safety findings (OSFs), ensuring accurate case capture and appropriate outcomes.
  • Compliance: Ensure compliance with global and local pharmacovigilance procedures, policies, and regulatory requirements.
  • Data Entry and Case Handling: Perform initial data entry, manage case information, and append additional details as received in the global intake system.
  • Continuous Improvement: Work within the Quality Management System (QMS) framework, supporting the implementation of Standard Operating Procedures (SOPs) to ensure high-quality case management.
  • Collaboration: Contribute to the quality and performance of product complaint and adverse event records in collaboration with cross-functional teams.

Qualifications

  • Basic Qualifications:
    • Master’s degree with 3 years of Drug Safety or Life Sciences experience OR
    • Bachelor’s degree with 5 years of Drug Safety or Life Sciences experience.
  • Preferred Qualifications:
    • Experience in pharmacovigilance or quality within the biotech, pharmaceutical, or medical device industry.
    • Previous experience with safety databases or corporate intake systems.
    • Strong understanding of global regulatory requirements (GMP, GxP).
    • Ability to manage workloads effectively within strict timelines and deliver high-quality results.
    • Familiarity with project management tools and a matrixed environment.

Skills & Knowledge

  • Ability to work with controlled documentation and compliance in pharmacovigilance processes.
  • Strong attention to detail with the ability to handle moderately complex tasks efficiently.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Project, Outlook).

Benefits & Culture

Amgen offers a competitive total rewards package, including base salary and comprehensive benefits. The company prides itself on fostering a culture of collaboration, inclusivity, and personal growth, ensuring that employees can thrive professionally and personally.