Associate Director, Safety Science

Responsibilities

• Responsible for supporting all safety science activities across Rhythm products in clinical development and post-approval stages ensuring the delivery of high-quality safety data.
• Lead ongoing safety surveillance activities, analysis, and interpretation of accumulating aggregate safety data from clinical trials and post-marketed sources in accordance with PV procedures, regulatory requirements and timelines.
• Identify, evaluate and manage emerging safety signals, maintain good documentation, and communicate any changes in the safety profile or benefit-risk assessment effectively (written and verbal) both internally and externally.
• Ensure consistent presentation of safety and risk management topics across various regulatory documents and enhance safety data quality and data integrity for all Rhythm products.
• Lead/co-lead planning and preparation of key global PV documents, including but not limited to Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Safety Update Report (PSUR), Development Safety Update Reports (DSURs), and Risk management Plans (RMPs).