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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

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To learn more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.