Director, REMS Global Safety Sciences, Medical Safety and Risk Management

Director, REMS Global Safety Scientist, Medical Safety and Risk Management

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 Director, REMS (Risk Evaluation and Mitigation Strategy) Global Safety Scientist, 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 Director, REMS Global Safety Scientist will be responsible for monitoring, evaluating, and managing the safety profile of assigned products, with a specialized focus on risk minimization activities required by global regulatory agencies such as the FDA and EMA.

The ideal candidate will leverage strong scientific writing, analytical skills, and regulatory expertise to ensure product benefits continue to outweigh their risks in both clinical trial and post‑marketing environments.

• Lead the authoring, development, and ongoing maintenance of REMS materials
• Lead the scientific review and authoring for REMS assessment reports
• Provide vendor oversight as needed
• Collaborate cross‑functionally for internal review of the full REMS assessment reports
• Author, contribute to, and strategically review aggregate safety reports overall and with a specific focus to REMS requirements and risks that require REMS
• Support readiness for internal audits and external regulatory inspections related to REMS activities
• Organize, direct, and manage technical and human resources to efficiently support the management of REMS safety data in accordance with FDA safety regulations
• Liaise with safety systems for required outputs
• Collaborate with medical risk management function
• Drive timely decisions and appropriately shift functional timelines, resources and priorities

• Conduct signal detection and management activities
• Develop and maintain risk management plans
• Manage direct report performance against goals; supporting and consulting as necessary
• Serve as functional owner of SOPs and Work Instructions related to functional area
• Serve as a point of escalation for issue resolution

• Health care professional (e.g., RN, pharmacist, or other life sciences experience) with a minimum of 6 years of relevant drug safety/pharmacovigilance experience; training in pharmacology, epidemiology or regulatory science is a plus
• Able to oversee and manage direct reports and vendors
• Excellent written/verbal communication and interpersonal skills
• Strong planning and organization skills
• Strong analytical skills and the ability to interpret complex clinical and safety data
• Excellent scientific writing and communication skills, with attention to detail
• Ability to work independently, manage multiple projects simultaneously, and collaborate effectively in a team environment

Concerned that you don’t check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other’s differences and recognize that teams thrive when everyone brings their unique experiences to the table. We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their whole selves to work. If you’re excited about this role but your previous experience doesn’t align perfectly with the job description, we still encourage you to apply.

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