Title: Sr. Associate - Case Management
Location: 100% Remote/Pacific Working Hours
Duration: 6 months (Possible Extension)
 
Purpose:

• To support the safety surveillance process for products by performing follow-up activities with patients and HCPs of individual case safety reports.
• Ensure vendor compliance with approved processes and training requirements.
• Oversee case quality of US ICSRs (CT and PM), including analysis and reporting of trends in quality measures.
• Point of accountability for managing one or more key vendor relationships for ICSR processing.
• Case processing point of contact for case-related activities with assigned business partners.
• Case processing point of contact for audit-related activities related to case processing.
• Accountable for measuring quality against contractual safety agreements.
• Accountable FDA point of contact for ICSR reporting.
• Submission of all individual safety reports to FDA, EMA, and Business Partners.

 Key Activities:

• Perform case review. Support the development and delivery of convention-related training material.
• Ensure compliance with reporting activities with timelines and criteria. Interface with local office staff, CROs, and business partners for case processing issues as necessary.
• Provide E2B submission support (nullification, redistribution). Address case-related queries from Business Partners.
• Support antibody re-testing coordination (non-LAO tasks for repeat testing).

 Knowledge and Skills:

• Understanding of global regulatory requirements for pharmacovigilance.
• Familiarity with clinical development processes. Case processing experience.
• Attention to detail. Competence in Argus safety systems and medical coding.
• Comprehensive English writing skills. Excellent phone conversation skills.
• Comprehensive knowledge of MS Office applications.
• Key Relationships: Case Management vendors, GQM/BPO, SOPS, MSRT, LSOs, Business Partners.

 Education & Experience (Basic):

• Bachelor's degree and 2 years of directly related experience OR associate’s degree and 6 years of directly related experience.

 

 


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.