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

Agios Pharmaceuticals Inc • Cambridge, MA

8d • Hybrid

About The Position

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, 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 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’ 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.

Requirements

• 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 current industry standards and benchmarks
• Able to oversee 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 achieve desired end-results
• Excellent written/verbal communication and interpersonal skills

Nice To Haves

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

Responsibilities

• 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 related to the reporting of REMS safety events to Agios
• Track and ensure follow-up of specified safety events in accordance with REMS enhanced pharmacovigilance requirements
• Organize, direct and manage technical and human resources to efficiently 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-related training materials for case management vendor and safety operations team
• Support internal audits and external regulatory inspections related to REMS activities
• Contribute to safety database upgrades and configuration changes; perform 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 point of escalation for issue resolution
• Drive timely decisions and appropriately shift functional timelines, resources and priorities

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.
• 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: 251-500 employees