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: aishwarya.t@ustechsolutionsinc.com
Internal Id: 25-39259
...Job Description: Product Owner About goTenna goTenna is advancing universal access to connectivity by building the world's most intelligent and scalable mobile mesh networks. goTenna is the world's leading mobile mesh networking company, providing off-grid connectivity...
...proactive Cybersecurity Analyst to join our security team. In this key role, you will be... ...compensation and training.Seniority level Seniority level Entry levelEmployment type Employment type... ...insuranceGet notified about new Cyber Security Analyst jobs in Boca Raton,...
Assistant Graphic Designer Location New York, NY : Description Assistant Concept Graphic Designer is responsible for assisting in conceptualizing and creating innovative, brand right seasonal graphics based on trend research. Responsible for working on initial development...
...Job Description Job Description SPECIFIC RESPONSIBILITIES: Manage cost accounting function of Tier 1 automotive supplier. Ownership in areas of:~ Overhead Cost Controlling~ Material costing, maintenance of cost accounting master date~ Product Cost...
...Independent Insurance Claims Adjuster in San Marcos, California 1 year ago Be among the first 25 applicants IS IT TIME FOR A CAREER CHANGE? INDEPENDENT INSURANCE CLAIMS ADJUSTERS NEEDED NOW! Are you ready to embark on a dynamic and in-demand career as an Independent...