Sr. Manager, Risk Evaluation & Mitigation Strategy (REMS)

Agios Pharmaceuticals Inc•Cambridge, MA

1d•$131,035 - $196,553•Hybrid

About The Position

Agios Pharmaceuticals is searching for a dynamic Sr. Manager, Risk Evaluation & Mitigation Strategy (REMS) to join our growing Medical Safety & Risk Management team in Safety Operations. We want someone who cares about this important work, and who’s driven to connect to our mission of helping our patient communities. The Sr. Manager, Risk Evaluation & Mitigation Strategy (REMS) will be responsible for participating in the implementation, and oversight of REMS programs. This role combines operational execution and cross-functional collaboration. The Sr. Manager will reside within Medical Safety & Risk Management (MSRM) and work closely with Regulatory Affairs, Medical Affairs, Market Access, Commercial, Supply Chain, and Legal teams, as well as external vendors, to support delivery of high-quality REMS programs that meet FDA requirements and support product success.

Requirements

Bachelor’s or Advanced degree in science, pharmacy, nursing, healthcare, or related field
Minimum of 5 years of relevant drug safety/pharmacovigilance experience
Strong knowledge of FDA REMS requirements 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
Strong orientation to teamwork
Excellent written/verbal communication and interpersonal skills

Nice To Haves

Audit and/or inspection experience in REMS and/or pharmacovigilance

Responsibilities

Participate in the implementation, oversight, and evaluation of REMS in alignment with the broader Program Strategy.
Act as the in-house REMS expert across the organization.
Assist in monitoring regulatory changes and proactively update strategies, policies, and procedures to align with FDA requirements and best practices.
Participate on cross-functional teams to integrate REMS considerations into product development, launch, and lifecycle management strategies.
Participate in the cross functional development of implementation and operational plans that support the REMS.
Perform REMS management and oversight in accordance with time, cost and quality commitments.
Participate in matrix teams across MSRM, Regulatory Affairs, Medical Affairs, Market Access, Marketing, Quality, Supply Chain, Commercial, and Legal.
Support provision of REMS strategy, progress, and compliance metrics to senior management and governance committees.
Perform and oversee timely execution of operational aspects of REMS and related case management/submission activities.
Participate in the review or creation of REMS related documentation, including FDA requests, and vendor-authored documents as required.
Support vendor oversight and management of day-to-day REMS operations, ensuring compliant enrollment, data collection, monitoring, and reporting.
Generate KPIs, dashboards, and compliance metrics to measure REMS program effectiveness.
Support readiness for regulatory inspections and audits; support noncompliance issue resolution, CAPA development and execution as needed.
Develop and deliver input, guidance and training on REMS for case management and submission PV vendor
General safety operations activities as assigned (eg: database user acceptance testing; vendor oversight)

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.
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.

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