LanceSoft
Cambridge, MA, USA
Job Description Remote: EST work hours EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS Bachelor of Science or Health Care Professional degree (e.G., RN, BSN, NP, PA, RPh) or equivalent qualification;advanced degree in scientific or medical field preferred. Minimum 10 years of relevant biotech/pharmaceutical experience. Excellent working understanding of safety database configuration and adverse event coding to direct advanced searches. In-depth knowledge of clinical trial methodology, pharmacovigilance regulations, safety data analysis and benefit-risk assessment, and understanding of drug development. Principal responsibilities include: Supports the Global Safety Lead (GSL) for assigned oncology pharmaceutical / biological / drug-device combined products. Responsible for safety surveillance, signal detection and risk management activities. Supports cross-functional assessment of benefit-risk profile and communication of safety information for assigned...