Job Description:
- In-depth pharmacovigilance case handling from case intake to submission of Individual Case Safety Reports (ICSRs)
- Extensive quality control of ICSRs to ensure compliance to internal and external health authority regulations (21 CFR FDA PostMarketing).
- Experience and familiarity working in safety databases (e.g., Argus)
- Identifies nonconformance and communicates via feedback or escalation as needed
- Education Level: Minimum bachelor’s degree, HCP degree is required e.g., pharmacist or nurse; advanced degree preferred
- Experience Level: 3+ Years of in Pharmacovigilance Case Processing
- Analytical thinker with proficiency working with safety databases
- Proficiency in MS Outlook, Excel, Word,
- Excellent written and verbal communication skills
- Pay: $29.75 hourly
- Hybrid Schedule: Onsite 3 days, remote 2 days per week
- 12-month contract, potential for extension