Pharmacovigilance Scientist I
211 Mount Airy Rd Basking Ridge, NJ 07920 US
The PV Scientist Pharmacovigilance's main role is to process and evaluate adverse events (AEs) received from clinical trials and/or post marketing sources to support drug development and ensure safety and efficacy of products. This includes SAE reconciliation, quality check (QC), late case investigations (CAPA), UAT (user acceptance testing), workflow monitoring and distribution (submissions) in a timely fashion to ensure compliance with local and global regulatory reporting.
Delivers high quality work, assesses individual and vendor/CRO work with minimal supervision. Executes strategic plans within multiple projects and can prioritize in accordance with strategy. Competent in identifying and understanding issues independently and can contribute to remediation plans Competent knowledge of pharmacology, clinical research and medical terminology, global data entry conventions and systems and procedures for application in daily work. Communicates effectively with team/project members using clear and effective verbal and written communication skills Effectively manages own workload to meet multiple deadlines in a timely manner. Understands functional role and others’ functional roles within the clinical trial process.
Bachelor’s degree in nursing, pharmacy, or healthcare related field with minimum of two (2) years of PV experience and knowledge of FDA regulations.
**CO/NY candidates may not be considered
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.