Case Management QA Vendor Associate

Case Management QA Vendor Associate

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.