The opportunity
Teva Pharmacovigilance unit is hiring for a 'Product Safety Group (PSG) Coordinator' (Pharmacovigilance Associate II) role to join the Medical Scientific Unit (MSU). In the MSU, we lead drug safety across the entire Teva portfolio and throughout various stages in the product lifecycle. Teva’s Safety Governance is a platform of cross-functional forums to ensure patient safety is continuously and proactively monitored throughout the lifecycle of Teva’s medicinal products. It is designed to ensure effective management of critical issues and associated activities in a compliant, effective, and coordinated manner keeping patient safety, health, and wellbeing at the center of all actions. Teva’s Safety governance consist of two main forums – the Product Safety Group (PSG) and the Corporate Safety Board (CSB) that operate in hierarchy and are led by Teva’s pharmacovigilance department.
The PSGs act as the first level of the safety governance. Each PSG meeting focuses on safety-related issues concerning a specific product form Teva's portfolio. PSGs are empowered to take critical decisions related to different relevant safety aspects of Teva’s products such as product safety labels of marketed products, risk minimization measures, safety aspects of clinical trials, etc. If deemed necessary, safety topics discussed in the PSG are escalated to the CSB – which is the most senior corporate governance body for safety related topics at Teva.
The PSG Coordinator coordinates Teva's safety governance related activities and works in collaboration with an international team across multiple time zones. The PSG Coordinator is well organized and reliable, operates successful in a stressful environment, and quickly adapts to shifting priorities.
How you’ll spend your day
End-to-end oversight for all PSG related activities and safety governance support for innovative products including:
Support MSU with PSG management.
Filing of PSG and CSB related documents
Routine compliance monitoring of the PSG/CSB tracker management and follow up on action items
QC of PSG meeting minutes distribution
Preparing periodic Safety Governance metrics reports
Close collaboration with the Safety Governance Subject Matter Expert (SME) including being familiar with all relevant activities (CSB management, PSMF handling, inspection readiness etc.) and serving as a backup
Taking part in preparing and providing training to newcomers or other MSU members in different topics related to safety governance, as required
Liaison contact for relevant vendors or PV systems team to support any technical issues related to the PSG and CSB tracker
Coordinating MSU reports and forums as per MSU needs
Cooperating with teams and MSU individuals, as well as with other relevant groups within and outside of Teva Pharmacovigilance
