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Case Management - Sr Associate

Spectraforce Technologies
United States, California, Thousand Oaks
Jul 30, 2026
Job Title: Case Management - Sr Associate Location: Remote Duration: 4+ Months (Possible extension) Top 3 Must Have Skill Sets Understanding of global regulatory requirements for pharmacovigilance Familiarity with clinical development processes Case processing experience Attention to detail Competence in lifecycle safety systems and medical coding (LSMV is a plus) Strong written and verbal communication skills Comprehensive knowledge on MS Office applications Description Supports the safety surveillance process for the client products by performing daily manual report review and follow up activities with patients and HCPs of individual case safety reports. Purpose To support the safety surveillance process for the client 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. Job Summary Case review / QC. Escalation of case level quality issues. Support convention-related training delivery. Supporting the reporting of Adverse Event Case Reports to FDA/EMA/Business Partners within time frames determined by regulations and contracts. Key Activities Supports the safety surveillance process for the client products by performing daily manual report review and follow up activities with patients and HCPs of individual case safety reports. Case review / QC. Escalation of case level quality issues. Support convention-related training delivery. Supporting the reporting of Adverse Event Case Reports to FDA/EMA/Business Partners within time frames determined by regulations and contracts. Case review / QC. Escalation of case level quality issues. Perform daily manual report review. Knowledge and Skills Understanding of global regulatory requirements for pharmacovigilance. Familiarity with clinical development processes. Case processing experience. Attention to detail. Competence in life cycle safety systems and medical coding. Comprehensive English writing skills. Excellent phone conversation skills. Comprehensive knowledge on 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 Soft Skills Ability to be a self starter and train remotely Able to work sufficiently remotely Day to Day Responsibilities Supports the safety surveillance process for the client products by performing daily manual report review and follow up activities with patients and HCPs of individual case safety reports. Case review / QC. Escalation of case level quality issues. Support convention-related training delivery. Supporting the reporting of Adverse Event Case Reports to FDA/EMA/Business Partners within time frames determined by regulations and contracts. Case review / QC. Escalation of case level quality issues. Perform daily manual report review. Employee Value Proposition Career growth Opportunity Industry experience Networking Possible Extension Yes Red Flags Over qualified (basic position, 10+ years experience would be way overqualified) Job hopping Interview Process Video conference