MUST HAVES:
1. Health care provider degree
2. In-depth PV case handling from case intake to submission of Individual Case Safety Reports (ICSRs)
3. Management experience
Job Requirements:
• 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).
• Management/Team Lead over safety case management processes/operations
• Familiarity and experience working in safety databases (e.g. Argus)
• Identifies nonconformance and communicates via feedback or escalation as needed
Qualifications:
• Education Level: Minimum Bachelor’s degree, HCP degree is required e.g., pharmacist or nurse; advanced degree preferred
• Experience Level: Total of 8+ years –– 5+ Years pharmacovigilance Team Lead/Management and 3+ pharmaceutical experience, pharmacovigilance required.
• Analytical thinker with proficiency working with safety databases
• Proficiency in MS Outlook, Excel, Word
• Excellent written and verbal communication skills
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