Must have :

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 Post Marketing).
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