Case Management QA Vendor Associate

4 weeks ago

Hyderabad, Telangana, India Amgen Technology Private Limited Full time
Job Description

As a Case Management QA Vendor Associate, you will be responsible for the quality and oversight of case intake and processing activities conducted by vendors. This role involves ensuring vendor compliance with approved processes and training requirements, managing relationships with business partners, and supporting safety reporting to regulatory bodies. You will be a key player in ensuring high-quality case processing, meeting all worldwide regulatory requirements, and maintaining a state of inspection readiness.

Roles & Responsibilities

- Vendor Oversight & Quality Assurance: You will oversee vendor activities, ensuring the quality of Individual Case Safety Reports (ICSRs) processed globally. This includes performing retrospective quality assurance, analyzing and reporting on QC trends, and managing vendor-related issues.
- Compliance & Training: Ensure vendors comply with approved processes and training requirements. You will provide vendors with the necessary resources and training and support the on-boarding and off-boarding of vendor staff.
- Safety Reporting & Regulatory Support: Submit all individual case safety reports to regulatory bodies like the FDA/EMA and business partners. You will act as a local safety office point of contact and provide essential support during audits and external inspections.
- Metrics & Analysis: Generate and distribute performance metrics related to retro QA and case corrections. You will also support the analysis of QC trends, including recommendations and actions to improve case quality.

Qualifications

- A Bachelor's degree with 3 years of directly related experience, an Associate's degree with 5 years of experience, or a High School diploma/GED with 7 years of experience.
- Previous experience managing teams, projects, or programs, or directing the allocation of resources.
- Expertise in safety case processing and a strong understanding of global regulatory requirements for pharmacovigilance.
- Experience in all aspects of case intake and processing in multiple global safety databases.
- Experience in supporting inspections or internal audits is preferred.
- Proficiency in Microsoft Suite (Word, Excel, PowerPoint, Project, Outlook).

Soft Skills

- Communication: Strong communication skills and the ability to interact with business partners, vendors, and other local safety offices.
- Attention to Detail: Meticulous attention to detail to ensure the quality of case processing and accurate reporting.
- Initiative: A high degree of initiative and self-motivation to undertake delegated activities and ensure inspection readiness.
- Problem-Solving: The ability to escalate and resolve case-related issues from vendors effectively.

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