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

Agios Pharmaceuticals Inc • Cambridge, MA

2d • Hybrid

About The Position

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.

Requirements

• 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 regulations and standards.

Nice To Haves

• 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. You may be just the right candidate for this role or another opening!

Responsibilities

• 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.

Benefits

• Deliberate Development. Your professional growth as one of our top priorities.
• Flexibility. We’re all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you’re at your best, we’re at our best.
• Premium benefits package. We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team. For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website.
• Competitive and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.
• Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
• Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We’re continuously looking to improve the inclusivity of our workforce.
• Commitment to community. We’re an active participant in the communities that surround us – the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 1-10 employees