Quality Assurance & Vendor Oversight Lead

2-18 years

Not Disclosed

Hyderabad

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.

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Quality Assurance & Vendor Oversight Lead

Job Description

About Amgen

Key Responsibilities

Qualifications

What You Can Expect

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