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Quality Assurance & Vendor Oversight Lead

2-18 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: Quality Assurance & Vendor Oversight Lead
Location: India - Hyderabad
Category: Safety
Job ID: R-203318
Work Location Type: On Site


About Amgen

Amgen is a global leader in biotechnology, committed to serving patients living with serious illnesses. Since 1980, Amgen has pioneered the biotech industry, focusing on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Diseases. By joining Amgen, you will contribute to transformative medicines that help improve patients’ lives while advancing your career in a collaborative, innovative, and science-driven culture.


Key Responsibilities

  • Vendor & Quality Oversight: Manage vendor relationships for case intake and processing activities, ensuring adherence to approved processes and compliance with regulatory standards.
  • Case Management: Oversee the processing of Individual Case Safety Reports (ICSR) globally for clinical trials and post-market cases.
  • Metrics Management: Supervise vendors’ case quality and key performance indicators, ensuring alignment with global regulatory authority requirements.
  • Training & Support: Provide training and resources to vendors for optimal case processing and manage quality control results.
  • Audit & Inspection Support: Support audits and external inspections related to case management and pharmacovigilance activities.
  • Staff Management: Supervise and support a team of 1-15 staff in Amgen India, focusing on case management and pharmacovigilance operations.
  • Continuous Improvement: Lead efforts to improve case quality, vendor operations, and compliance with contractual agreements.
  • Cross-functional Collaboration: Foster relationships with global teams, business partners, and regulatory bodies to ensure seamless case processing and adherence to safety regulations.

Qualifications

  • Education:
    • Doctorate degree with 2 years of related experience OR
    • Master’s degree with 8 to 10 years of related experience OR
    • Bachelor’s degree with 10 to 14 years of related experience OR
    • Diploma with 14 to 18 years of related experience.
  • Experience:
    • At least 4 years of managerial experience overseeing people, teams, or projects.
    • Expertise in case management and vendor relationships, with knowledge of global regulatory requirements for pharmacovigilance.
    • Proficient in Microsoft Suite (Word, Excel, PowerPoint, Project, Outlook).
    • Extensive experience in managing and mentoring teams.

What You Can Expect

  • Professional Growth: Amgen is dedicated to supporting your career development through competitive benefits and a collaborative culture that nurtures innovation.
  • Global Impact: As part of Amgen, you will make a direct contribution to improving the quality of life for patients worldwide, while working in an inclusive and ethical environment.