Location: Plainsboro ,NJ-08536-Hybrid
Duration: 12 months (Potential for extension)
"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 Description:
Seeking an experienced Pharmacovigilance Team Lead/Manager to oversee safety case management from intake through submission of Individual Case Safety Reports (ICSRs). The role involves ensuring compliance with regulatory requirements, managing a team, and maintaining high-quality case documentation using safety databases such as Argus. Candidates must have a healthcare degree, at least 8 years of relevant experience including 5+ years in PV leadership, strong analytical skills, and excellent communication abilities.
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:
• 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
Education Level:
Minimum Bachelor’s degree, HCP degree is required e.g., pharmacist or nurse; advanced degree preferred
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
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.
Recruiter Details:
Name: Aishwarya Tiwari
Email: [email protected]
Internal Id: 25-39259
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