Position Title: Case Management – Senior Associate
Work Location: Thousand Oaks, CA, USA, 91320
Assignment Duration: Initial 4-Month Contract (Possible Extension)
Work Arrangement: Fully Remote – Any Time Zone
 
Position Summary
The Senior Associate, Case Management, supports the safety surveillance process for company products by performing follow-up activities with patients and healthcare professionals (HCPs) related to individual case safety reports (ICSRs). This role ensures vendor compliance with approved processes, timelines, and training requirements while maintaining the highest standards of data quality and regulatory compliance.
 
Background & Context
Key Responsibilities

• Oversee case quality of U.S. ICSRs (clinical trial and post-marketing), including trend analysis and quality measure reporting.
• Serve as the primary point of accountability for managing one or more key vendor relationships for ICSR processing.
• Act as the case processing point of contact for case-related activities with assigned business partners and audit-related activities.
• Ensure quality metrics align with contractual safety agreements.
• Serve as the FDA point of contact for ICSR reporting.
• Manage submission of all individual safety reports to FDA, EMA, and business partners.
• Perform detailed case reviews to ensure accuracy and compliance.
• Support development and delivery of convention-related training materials.
• Ensure compliance with reporting timelines, criteria, and regulatory requirements.
• Interface with local office staff, CROs, and business partners regarding case processing issues.
• Provide E2B submission support (nullification and redistribution).
• Address case-related queries from business partners.
• Support antibody re-testing coordination (non-LAO tasks for repeat testing).

 
Day-to-Day Responsibilities

• Perform case follow-up activities with patients and HCPs.
• Monitor and ensure vendor compliance with processes and training standards.
• Oversee case quality, analyze trends, and prepare relevant reports.
• Manage case processing activities and support audits.
• Serve as regulatory liaison for FDA submissions and communication.

 
Qualifications & Experience

• Education:
  • Master’s degree, OR
  • Bachelor’s degree with 2 years of experience, OR
  • Associate’s degree with 6 years of experience, OR
  • High school diploma / GED with 8 years of experience

 

• Knowledge & Skills:
  • Strong understanding of global regulatory requirements for pharmacovigilance
  • Familiarity with clinical development processes
  • Hands-on case processing experience
  • Proficiency in Argus safety systems and medical coding
  • Excellent written and verbal English communication skills
  • Strong attention to detail and organizational skills
  • Competence in Microsoft Office Suite

 
Key Relationships

• Case Management Vendors
• GQM/BPO
• SOPS
• MSRT
• LSOs
• Business Partners

 
Top 3 Must-Have Skill Sets

1. Strong communication and interpersonal skills
2. Prior pharmacovigilance experience or exposure
3. Excellent organizational and time management skills

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 24.00/hr.