Case Management - Sr Associate
Planet Pharma · California, United States · 2 mo ago
OTHRContract
Key Activities
- Supports the safety surveillance process for 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.
Knowledge and Skills
- Understanding of global regulatory requirements for pharmacovigilance.
- Familiarity with clinical development processes.
- Case processing experience.
- Attention to detail.
- Cumulative 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