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Job Requirements of Pharmacovigilance QC lead:
-
Employment Type:
Contractor
-
Location:
Plainsboro Township, NJ (Onsite)
Do you meet the requirements for this job?
Pharmacovigilance QC lead
Careers Integrated Resources Inc
Plainsboro Township, NJ (Onsite)
Contractor
Job Title: Pharmacovigilance QC lead
Location: Plainsboro, NJ- hybrid (at least 3 days/week onsite is expected)
Duration:12 Months+
Pay Range: $48.82/hr. on W2
Must have:
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
Location: Plainsboro, NJ- hybrid (at least 3 days/week onsite is expected)
Duration:12 Months+
Pay Range: $48.82/hr. on W2
Must have:
- Health care provider degree
- In-depth PV case handling from case intake to submission of Individual Case Safety Reports (ICSRs)
- 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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