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Sr. Assoc Pharmacovigilance Operations

Advanced Bio-Logic Solutions Corp
Thousand Oaks, CA Full Time
POSTED ON 4/6/2024
Top 3 Must Have Skill Sets:    
  • Safety database experience
  • Acquisition experience
  • Inspection facing experience
Day to Day Responsibilities:    

REMOTE

Supports the safety surveillance process for Amgen products by performing daily manual report review, acquisition activities, follow up activities with patients and HCPs of individual case safety reports and support audits and inspections activities.

Case Management - Sr Associate

Purpose:
  • To support the safety surveillance process for Amgen 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 - Job Summary - Supports the safety surveillance process for Amgen 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 Argus safety systems and medical coding. Comprehensive English writing skills. Excellent phone conversations 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

Red Flags:    
  • No PV/safety database experience
  • Overqualified candidates - someone with 10-15 years of experience, this is more entry level role. Someone with PHD degree.

PAY RATE : $25-$27/hr on W2

"This posting is for Contingent Worker, not an FTE"

Salary.com Estimation for Sr. Assoc Pharmacovigilance Operations in Thousand Oaks, CA
$71,774 to $92,381
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