Sr. Manager,Safety Operations​/Case Management, Medical Safety and Risk Management

Sr. Manager, Safety Operations / Case Management, Medical Safety and Risk Management

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Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for rare diseases – and make a bigger difference in their lives.

In the U.S., Agios markets a first‑in‑class pyruvate kinase (PK) activator for the treatment of hemolytic anemia in adults with PK deficiency. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha‑ and beta‑thalassemia, sickle cell disease, pediatric PK deficiency and MDS‑associated anemia.

Agios Pharmaceuticals is searching for a dynamic Sr. Manager, Safety Operations / Case Management to join our growing Medical Safety and Risk Management team. We want someone who cares about this important work, and who’s driven to connect to our mission of helping these patient communities. The Sr. Manager will be responsible for overseeing the execution of deliverables associated with case processing, expedited reporting and submission of designated aggregate safety reports, with a specialized focus on risk minimization activities required by global regulatory agencies such as the FDA and EMA.

This position ensures individual reports from all sources (spontaneous, literature, product/patient support programs, market research programs, clinical trials (pre‑ & post‑approval), medical information, call centers, commercial affiliates, partner companies, health authorities, post‑marketing commitment studies, etc.) are collected, managed and reported according to Agios’ global SOPs and global adverse event regulations and guidelines.

This position oversees case processing activities, processes, procedures, and interdepartmental projects involving safety data captured in the global safety database. This position collaborates within MSRM and with other company functional areas and cross‑functional teams, and interacts with CROs, vendors, partners, and study teams on all aspects of safety data collection and reporting.

• Contribute to the authoring, development, and ongoing maintenance of REMS materials
• Participate cross‑functionally in the internal review of REMS assessment reports
• Conduct and monitor reconciliation activities related to the reporting of REMS safety events to Agios
• Track and ensure follow‑up of specified safety events in accordance with REMS enhanced pharmacovigilance requirements
• Organize, direct and manage technical and human resources to efficiently support the capture and management of REMS safety data in accordance with FDA safety regulations and ICSR standards
• Contribute to signaling and aggregate reporting activities of REMS and other safety data through ensuring quality and accuracy of individual cases through collaboration with Global Safety Sciences
• Ensure development and delivery of REMS‑related training materials for case management vendor and safety operations team
• Support internal audits and external regulatory inspections related to REMS activities
• Contribute to safety database upgrades and configuration changes; perform user acceptance testing
• Collaborate internally and with vendors to establish and monitor key performance indicators (KPIs) that are relevant and in alignment with regulations/industry standards
• Provide subject matter expertise and collaborate with MSRM Standards, Compliance and Training colleagues, Pharmacovigilance Quality Assurance colleagues and vendors to ensure compliance with world‑wide regulations for case quality and timely submissions
• Support MSRM and cross‑functional compliance…