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 rare 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 Operations/Case Management 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
Sr. Manager, Safety Operations / Case Management will be responsible for overseeing the execution of deliverables associated with case processing, expedited reporting and submission of designated aggregate safety reports. This position ensures individual reports from all sources (spontaneous, literature, product/patient support programs, market research programs, clinical trials (pre-& post approval), medical information, call centers, commercial affiliates, partner companies, health authorities, post marketing commitment studies, etc.) are collected, managed and reported according to Agios’s global SOPs and global adverse event regulations and guidelines.
This position oversees case processing activities, processes, procedures, and interdepartmental projects involving safety data captured in the global safety database. This position collaborates within MSRM and with other company functional areas and cross-functional teams, and interacts with CROs, vendors, partners, and study teams on all aspects of safety data collection and reporting.
What you will do:
- Organize, direct and manage technical and human resources to efficiently support the capture and management of individual safety reports in accordance with global safety regulations in a scalable approach
- Develop, maintain, ensure training, and enforce written procedures related to the collection requirements, processing and reporting of events from clinical trials and marketed sources to ensure proactive surveillance of Agios products
- Contribute to safety database upgrades and configuration changes; perform user acceptance testing
- Provide input and guidance to submissions and case processing vendor teams; facilitate training and develop training materials for vendor training
- Contribute to signaling and aggregate reporting activities through ensuring quality and accuracy of individual cases through collaboration with Safety Sciences
- Participate as Safety Operations subject matter expert on Clinical Trial teams
- Collaborate internally and with vendors to establish and monitor key performance indicators (KPIs) that are relevant and in alignment with regulations/industry standards
- Provide input to partner safety data exchange agreements and support the relationship as a primary point of contact
- Provide subject matter expertise and collaborate with MSRM Standards, Compliance and Training colleagues, Pharmacovigilance Quality Assurance colleagues and vendors to ensure compliance with world-wide 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
- Serve as functional owner of SOPs, Work Instructions and Job Aids related to functional area
- Represent the functional area in internal committees and with external parties (e.g. partners, regulatory agencies)
- Serve as case management SME during audits and inspections
- Serve as a point of escalation for issue resolution
- Drive timely decisions and appropriately shift functional timelines, resources and priorities
- Collaborate with relevant departments within Agios to determine budget and resources within area of responsibility
What you bring:
- Health care professional (e.g. RN, pharmacist) or other life sciences
- BS/BA with a minimum of 5 years of relevant drug safety/pharmacovigilance experience
- Knowledge of current industry standards and benchmarks
- Able to oversee and manage vendors
- Extensive knowledge and experience with MedDRA and WhoDD coding dictionaries
- Experience with software-based drug safety systems (ARGUS, ARISg, or equivalent)
- 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
- Consistently and effectively balance decisions with imperatives for ethics and efficacy
- Strong orientation to teamwork
- Strong negotiation skills to effectively drive discussions and decisions toward desired end-results
- Excellent written/verbal communication and interpersonal skills
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. 
