Develop in vitro assays for evaluating mechanisms of drug resistance, drug differentiation and pharmacodynamic marker identification (develop resistant cell lines, make stable knock-downs and knock-ins, cellular trafficking studies)
The SS is responsible for collecting all safety data relevant to the issue to be evaluated. The execution of this task is typically a joint effort between the Global Safety Lead (GSL) and the SS for medically complex topics.
Independently perform sample testing, data processing, data report and data interpretation for biosimilar development and stability studies, CQA assessment, similarity assessment and forced degradation.
The Pharmacovigilance Scientist (PVS) will serve as a core member of the safety team and is responsible for performing proactive pharmacovigilance activities on a product, or group of products in a therapeutic area or franchise, in partnership with the Global Safety Officer (GSO) to evaluate safety data and signals for both marketed products and products in clinical development.
Plan, design and implement experiments to develop novel formulations with limited or no supervision.Work with lipid-based or polymer nanoparticle formulations using various equipment including mixers, pumps, lyophilizers.
In this role, you will perform a wide variety of moderately and highly complex tasks and analysis of human fluids and tissues, using manual procedures as well as operating various laboratory equipment and automated analyzer systems.
This position has responsibilities for a wide variety of Pharmacovigilance activities for different drug development programs. Responsibilities include the coordination and monitoring of all stages of adverse event processing, tracking, review, evaluation, reconciliation and reporting in cooperation with our clients' global organization and third party CROs involved in remote/outsourced activities.