General Summary:

The Senior Manager of Safety Operations will oversee and manage the safety reporting operations in support of Orano Med clinical trials. This role ensures the accurate and timely collection, analysis, and reporting of safety data, in compliance with regulatory requirements and company policies. The ideal candidate will possess strong leadership skills, extensive knowledge of pharmacovigilance processes, and a deep understanding of clinical trial safety operations.

Job Duties and Responsibilities: 

• Manage outsourced safety vendor(s) and processes to ensure compliance with contractual agreements and regulatory requirements.
• Ensure compliance with all relevant regulatory guidelines and requirements (e.g., FDA, EMA, ICH) related to clinical trial safety reporting including the accurate and timely entry of safety data into safety databases. Develop and track key performance indicators (KPIs) for the central safety vendor and clinical resource organizations (CROs) managing individual studies.
• Develop and maintain standard operating procedures (SOPs) and work instructions for oversight of outsourced safety operations.
• Put in place study level safety processes and safety reporting mechanisms (e.g. write safety management plans, oversee safety gateway set up and maintenance).
• Manage writing of safety reports, including periodic safety update reports (PSURs), Development Safety Update Reports (DSURs).
• Liaise with regulatory authorities regarding safety reporting and provide responses to safety-related inquiries.
• Lead initiatives to implement new technologies and tools to support safety data management and reporting.
• Stay current with industry trends, regulatory updates, and best practices in pharmacovigilance and safety operations.