Sr. Manager, Risk Evaluation & Mitigation Strategy; REMS

Who we are

At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture – one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve. We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion – because our differences shape how we hire, collaborate, and innovate.

Our team’s proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities. Our commitment is more than scientific – it’s deeply personal, grounded in the meaningful connections we have built. To learn more, visit  and follow Agios on Linked In and X.

Agios Pharmaceuticals is searching for a dynamic Sr. Manager, Safety Operations/Case Management to join our growing Medical Safety and Risk Management team. This role 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.

The position ensures individual reports from all sources are collected, managed, and reported according to Agios’ global SOPs and adverse event regulations and guidelines.

• 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 utilizing the Liver Adverse Event Report Form (LAERF)
• Ensure processing and expedited submission of 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 global regulations and 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 worldwide regulations for case quality and timely submissions
• Support MSRM and cross-functional compliance activities through the compilation and delivery of compliance metrics at required intervals/frequencies
• Represent the functional area in internal committees and with external parties (e.g. partners, regulatory agencies)
• Serve as a point of escalation for issue resolution
• Drive timely decisions and appropriately shift functional timelines, resources and priorities

• BS/BA with health care professional (e.g. RN, pharmacist) or other life sciences experience
• Minimum of 3-5 years of relevant drug safety/pharmacovigilance experience
• Strong knowledge of FDA REMS requirements
• Knowledge of current industry standards and benchmarks
• Able to oversee and manage vendors
• Extensive experience with MedDRA and WhoDD coding dictionaries
• Experience with software-based drug safety systems (e.g. ARGUS, ARISg)
• Excellent computer skills (MS Office)
• Advanced knowledge of US and EU pharmacovigilance regulations for development and marketed products
• Strong planning, process mapping, and organization skills
• Strong orientation to teamwork
• Strong…