Position summary:

• Oversee Patient Safety activities for assigned oncology compounds.

• Prepare and review safety documents (DSURs, PSURs, RMPs).

• Requires MD and expertise in FDA, EU, and ICH pharmacovigilance guidelines.

This Senior Director/Director Safety Physician role in Oncology involves overseeing all Patient Safety activities for assigned compounds. Key responsibilities include managing safety signals, responding to regulatory queries, preparing and reviewing safety documents (DSURs, PSURs, RMPs), and providing safety input on clinical documents such as protocols and study reports. The role requires leadership of cross-functional Safety Monitoring Teams and representation of GPS on internal and external committees, including safety oversight and independent data monitoring teams. The candidate must proactively develop strategies for GPS activities, participate in SOP development, and engage in continuous improvement efforts.

Requirements include expertise in applying FDA, EU, and ICH guidelines for pharmacovigilance in clinical trials and post-marketing, acting as an internal and external safety expert, and using safety databases for case reviews. Strong communication skills to present and defend safety findings and risk management strategies are essential, and an MD is highly preferred.