Sr. Manager, Safety Systems Lead

Who we are:

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 genetically defined 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.

The impact you will make:

Agios Pharmaceuticals is searching for a dynamic Sr. Manager, Safety Systems Lead to join our growing Medical Safety and Risk Management team. The Sr. Manager, 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:

• Serve as the technical lead and SME for the company safety database and ancillary applications.
• Oversee and manage safety systems vendors including input into Statements of Work, Roles/Responsibilities, KPI’s etc.
• Lead safety system upgrade activities including developing and overseeing project plan, deliverables, testing and documentation.
• Review and Approve computer system-related technical documents (e.g. Validation Plan, Validation Summary Reports, User Acceptance Testing, etc.) on behalf of the Business Owner, as needed.
• Contribute to/author department procedures relevant to safety systems.
• Manage relationships with Agios QA and IT teams supporting compliance and system functionality, and internal functions who inform and/or consume data from the safety database.
• Ensure that the safety database is consistently in a validated state.
• Responsible for safety system administration and associated systems (relational databases, EDI gateways, integrations with document management, OCR and other dependent systems).
• Configuration and maintenance of safety database, including products, studies, code lists, users/security, reporting rules, and configuration of E2B reporting for gateway submissions.
• Oversight and facilitation of system updates including dictionary updates such as MedDRA, WHO Drug Dictionary and Important Medical Events list.
• Manage required safety database configuration, upgrades and patches based on regulations and business needs.
• Program complex queries and reports in relational database and analytical systems/applications such as Oracle RDBMS, Tableau or Spotfire.
• Perform periodic ad-hoc data extractions.
• Provide expert input to data mapping and integration, and migration/conversion activities.
• Ensure database adherence to SOPs, GxP, ICH, FDA regulations, EU Annex 11 and 21 CFR Part 11.
• Maintain knowledge of regulations, current industry standards and benchmarks.
• Manage direct reports, as applicable.

What you bring:

• BS Computer science or equivalent qualification
• Minimum 5-7 years pharmaceutical/biotech industry or related experience in drug safety/risk management databases, including vendor oversight and management.
• Experience leading/facilitating data migrations and system upgrades.
• Extensive experience in ensuring adherence to SOPs, GxP, ICHFDA regulations, EU Annex 11 and 21 CFR Part 11
• Strong skills and extensive experience in database administration, data collection and reporting
• Demonstrated skills in relational database technology and query (SQL) development.
• Advanced knowledge of US, UK and EU pharmacovigilance regulatory requirements
• Excellent problem-solving and solution-generating skills
• Strong planning, organization, written and oral communication skills.
• Ability to balance decisions with imperatives for ethics, safety and efficacy.
• Strong orientation to teamwork
• Strong negotiation skills: can effectively drive discussions and decisions toward desired end-results

Preferred Qualifications

People management experience preferred.

Work Location:

Location Agnostic: Work location for this role is based on employee's individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.

What we will give you:

• 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.
• Competitive performance-based compensation. This includes both short- and long-term incentives that are connected to our business strategy.
• 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.

Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.