Category: Scientific & Clinical
Job ID: 219984
Date Posted: 05/04/2021
Title: Pharmacovigilance Scientist I
Location: Basking Ridge, NJ
Start date: ASAP
Max Subs: 3Duties:
The Scientist Pharmacovigilance main role is to process and evaluate adverse events (AEs) received from clinical trials and/or postmarketing sources to support drug development and ensure safety and efficacy of Daiichi Sankyo products. This includes data collection, entry, evaluation, follow up, and distribution 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.