Quality Assurance Case Processing Specialist

3 days ago

Hyderabad Secunderabad Telangana, India beBeeAssociate Full time ₹ 1,04,000 - ₹ 1,30,878

As a Quality Assurance Associate, you will be responsible for ensuring the quality of case intake and processing activities conducted by vendors.

This role involves vendor oversight, compliance with approved processes and training requirements, managing relationships with business partners, and supporting safety reporting to regulatory bodies.

Key Responsibilities
  • Vendor Oversight & Quality Assurance: You will oversee vendor activities, ensuring the quality of Individual Case Safety Reports (ICSRs) processed globally.
  • Compliance & Training: Ensure vendors comply with approved processes and training requirements.
  • Safety Reporting & Regulatory Support: Submit all individual case safety reports to regulatory bodies like the FDA/EMA and business partners.
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.
Requirements
  • Proficiency in Microsoft Suite (Word, Excel, PowerPoint, Project, Outlook).
  • Strong communication skills and the ability to interact with business partners, vendors, and other local safety offices.
  • Meticulous attention to detail to ensure the quality of case processing and accurate reporting.
  • The ability to escalate and resolve case-related issues from vendors effectively.

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