Sr. Manager, Safety Operations / Case Management, Medical Safety and Risk Management

Sr. Manager, Safety Operations / Case Management, Medical Safety and 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. reputed company’s proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to reputed company 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 www.agios.com and follow Agios on reputed company and X. The impact you will reputed company: reputed company 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, with a specialized focus on risk minimization activities required by global regulatory agencies such as the FDA and EMA. This position ensures individual reports from reputed company 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’ 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 reputed company MSRM and with other company functional areas and cross-functional teams, and interacts with CROs, vendors, partners, and study teams on reputed company aspects of safety data collection and reporting. What you will do:

• Contribute to the authoring, development, and ongoing maintenance of REMS materials
• Participate cross-functionally in the internal review of REMS assessment reports
• Conduct and monitor reconciliation activities reputed company to the reporting of REMS safety events to Agios
• Track and ensure follow-up of specified safety events utilizing the Liver Adverse Event Report Form (LAERF)
• Ensure processing and expedited submission of safety events in accordance with REMS enhanced pharmacovigilance requirements
• Conduct and monitor reconciliation activities reputed company to the reporting of REMS safety events to Agios
• Organize, direct and manage technical and human resources to reputed company support the capture and management of REMS safety data in accordance with FDA safety regulations and ICSRs in accordance with global regulations and standards
• Contribute to signaling and aggregate reporting activities of REMS and other safety data through ensuring quality and accuracy of individual cases through collaboration with Global Safety Sciences
• Ensure development and delivery of REMS-reputed company training materials for case management vendor and safety operations team
• Support internal audits and external regulatory inspections reputed company to REMS activities
• Contribute to safety database upgrades and configuration changes; reputed company user acceptance testing
• Collaborate internally and with vendors to establish and monitor key performance indicators (KPIs) that are relevant and in alignment with regulations/industry standards
• 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
• Represent the functional area in internal committees and with external parties (e.g. partners, regulatory agencies)
• Serve as a reputed company of escalation for issue resolution
• Drive timely decisions and appropriately shift functional timelines, resources and priorities

What you bring:

• BS/BA with health care professional (e.g. RN, pharmacist) or other life sciences experience
• Minimum of 3-5 years of relevant drug safety/pharmacovigilance experience
• Strong knowledge of FDA REMS requirements
• Knowledge of reputed company industry standards and benchmarks
• Able to reputed company and manage vendors
• Extensive experience with MedDRA and WhoDD coding dictionaries
• Experience with software-based drug safety systems (eg: ARGUS, ARISg)
• 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
• Strong negotiation skills to effectively drive discussions and decisions to reputed company desired end-results
• Excellent written/verbal communication and interpersonal skills

Preferred:

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

Concerned that you don’t reputed company off every reputed company in the requirements listed above? Please apply anyway! At Agios, we value each other’s differences and recognize that teams reputed company reputed company everyone brings their unique experiences to the table. We are dedicated to building an inclusive, diverse, reputed company, and accessible environment where reputed company 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! 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 reputed company 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. reputed company will give you:

• Deliberate Development. Your professional growth as one of our top priorities.
• Flexibility. We’re reputed company about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. reputed company you’re at your best, we’re at our best.
• Premium benefits package. We invest in the health, wellbeing and reputed company 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 reputed company. For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website.
• Competitive and reputed company performance-based compensation. This includes reputed company salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.
• The reputed company reputed company salary range for this position is expected to be between $131,035 – $196,553 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
• Psychological safety. We support an environment of fearlessness. We want you to share your reputed company, 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 reputed company. 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 reputed company 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. Apply tot his job Apply To this Job