Associate Director, Safety Systems Lead, Medical Safety & Risk Management

Associate Director, Safety Systems Lead, Medical Safety & Risk Management

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 . The impact you will make:
Agios Pharmaceuticals is searching for a dynamic Associate Director, Safety Systems Lead to join our growing Medical Safety & 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 Associate Director, Safety Systems Lead will be responsible for all technical aspects of the safety database environment, supporting business requirements for case processing and submission compliance, facilitating and managing interfaces with other systems, providing data to all relevant parties, serving as the safety systems technical subject matter expert and overseeing relevant safety systems vendors.

What you will do:

Own the safety systems strategy and roadmap, serving as the enterprise technical lead and SME for the safety database, safety reporting, and safety signaling applications; set standards and ensure fit-for-purpose, scalable use. Serve as the administrator of the safety systems ecosystem (relational databases, EDI gateways, integrations with document management, OCR, and other dependent systems), including configuration standards and ongoing maintenance (products, studies, code lists, users/security, reporting rules, and E2B gateway settings).

Direct system releases/patches and controlled updates (e.g., MedDRA, WHO Drug Dictionary, Important Medical Events) with robust impact assessment, testing, documentation, and change control. Set standards for and oversee complex queries, periodic reporting, and ad-hoc data extractions across safety systems and analytical tools/applications (e.g., PV Reports, Spotfire), ensuring data quality, enabling operational and compliance insights, and providing accurate data outputs and periodic reports to support data analyses.

Provide technical leadership for data mapping, integrations, and migration/conversion activities, driving clear requirements, validation of outcomes, and cross-functional execution. Maintain expert knowledge of safety systems capabilities, Artificial Intelligence/Machine Learning, regulations, current industry standards and benchmarks; translate insights into recommendations and roadmap decisions for safety systems. Lead cross-functional partnerships with QA, IT, and business stakeholders and govern safety systems vendors (SOWs, roles/responsibilities, KPIs/SLAs, escalations, and continuous improvement);

drive creation and maintenance of safety systems procedures and work instructions and provide input to forecasting and budget management. Ensure safety systems remain continuously compliant, validated, and inspection-ready by overseeing computer system validation (CSV) deliverables (e.g., Validation Plans, Summary Reports, UAT), partnering with QA on audit trails/evidence, and maintaining adherence to SOPs, GxP, ICH, FDA regulations, EU Annex 11, and 21 CFR Part 11 Manage, lead and develop direct reports, as applicable, including coaching, performance management, workload planning, and capability building.

What you bring:

Bachelor's degree in Computer Science, Information Systems, or equivalent qualification. 8-10+ years of pharmaceutical/biotech (or related) experience in pharmacovigilance/safety systems administration. Extensive skills in safety systems administration/governance (safety database, EDI gateway, integrations), including configuration, releases/patches and dictionary updates (e.g., MedDRA/WHODD), and change control with testing/documentation. Advanced SQL skills and in-depth experience with safety reporting/analytics tools (e.g., PV Reports, Spotfire, Tableau) to enable complex reporting and ad-hoc extracts.

Strong leadership, communication, stakeholder influence, and vendor governance/negotiation skills; able to drive decisions to closure with sound judgment and a focus on ethics, patient safety, and data integrity. Experience leading data mapping, integrations, and complex migrations/conversions and system upgrades. Expertise ensuring safety systems compliance/inspection readiness, including CSV oversight and adherence to GxP, ICH, and world-wide…