Senior Manager/Associate Director, Case Management Oversight/Medical Review Lead

Company: Agios Pharmaceuticals Inc
Location: Cambridge
Posted on: April 5, 2021

Job Description:

Senior Manager/Associate Director, Case Management Oversight/Medical Review Lead Location Agios Pharmaceuticals HQ Job Code 1473 # of openings 1 Senior Manager/Associate Director, Case Management Oversight/Medical Review Lead, Medical Safety & Risk Management Agios (agios.com) is a biopharmaceutical company committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic diseases. We are growing rapidly with an active research and discovery pipeline across both therapeutic areas. Agios has two approved oncology precision medicines and multiple first-in-class investigational therapies in clinical and/or preclinical development. Agios Pharmaceuticals is searching for a dynamic Case Management Oversight/Medical Review Lead to join our Medical Safety & Risk Management (MSRM) team. This position is a role that bridges safety case management and report submissions oversight with safety surveillance/risk management. The successful candidate will effectively interface, cross-functionally, at all levels of the organization as well as externally with business partners and vendors, ensuring alignment with contractual agreements, company policies, ICH guidelines and global regulations throughout the product lifecycle. The individual in this role is also responsible for providing direction and training to internal staff and third-party vendors. The ability to work in a dynamic, changing environment in order to meet corporate goals and patient needs is essential. The Case Management Oversight/Medical Review Lead reports to the Director of MSRM Case Management and serves as a point of contact for the medical review and case processing teams, for investigational and marketed products. The person in this position possesses significant knowledge of case processing, inclusive of medical review, and report submissions in order to ensure timeliness and quality of Agios' individual case safety reports and will be responsible to perform Quality Control review of the vendor's work and provide feedback directly to the vendor. The person in this position will also participate in or lead special projects, represent MSRM Operations on Clinical Trial Working Groups, and be an expert resource for all aspects of safety case management and medical review to develop and support the safety profiles of all Agios products. Key Responsibilities

• Provide input to key performance indicators (KPIs) and Key quality indicators (KQI) for safety data processing, medical review and safety reporting/submissions.
• Quality Control review of sample of safety cases to ensure accuracy and quality of case processing performed by a vendor.
• Develop and administer training to medical review and case processing colleagues/vendors.
• Medical Review Oversight
  • Ensure quality and timeliness of outsourced Medical Review activities and, when necessary, perform medical review of ICSRs (narratives, coding, expectedness, causality and seriousness).
  • Participate in safety surveillance and risk management activities, as requested.
  • Maintain reference safety information for medical review team and demonstrate knowledge of RSI for all Agios products .
  • Case Processing Oversight
    • Triage drug safety inbox, identifying safety data for processing and responding to emails requiring action or resolution.
    • Provide notification and/or seek input on safety cases from Agios clinical and medical safety representatives when appropriate.
    • Oversee submission of expedited ICSRs as well as distribution of periodic safety reports to health authorities, EC/IRB, PIs and partners, as applicable. Take urgent action to investigate submission errors in collaboration with safety systems team to ensure on time reporting.
    • Generate MedWatch, CIOMS, and other required submission documents for reportable cases and liaise with internal and external personnel to ensure timely expedited reporting.
    • Perform/ oversee reconciliation of safety data with data management, business partners and vendors, as applicable.
    • Collaboration with Internal and External Partners
      • Communicate directly with 3 rd parties regarding processing and timely exchange of safety data.
      • Participate in cross-functional teams and contribute to/review key clinical and regulatory documents (e.g. protocols and associated documents, aggregate reports).
      • Contribute to, maintain and implement department SOPs, Work Instructions, tools and operational plans (e.g. Safety management plans) owned by Agios and/or governing work performed by 3 rd party vendors and partners.
      • Participate in safety database testing and data migrations.
      • Support the Quality Management System
        • Identify and escalate potential compliance or quality issues.
        • Participate in/develop preventative and corrective action plans arising from quality events, audits and inspections.
        • Represent MSRM during inspections, as applicable.
        • Bachelors' Degree or higher in life sciences (e.g. biology, biochemistry, BSN, Pharmacist, M.D., or D.O.)
        • Minimum 3 - 5 years of case processing experience, including Medical Review, in the biotechnology / pharmaceutical industry
        • Demonstrated ability to oversee and manage drug safety vendors
        • Experience performing/overseeing Medical Review
        • Solid understanding of expedited safety reporting
        • Expertise with MedDRA dictionary coding
        • Expertise with software-based drug safety systems (ARGUS, ARISg, or equivalent)
        • Excellent communication and interpersonal skills including the ability to work on teams
        • Excellent written and spoken English
        • Solid knowledge of ICH and global regulations for clinical development and post-market activities pertaining to safety data collection and reporting
        • Ability to successfully prioritize and multi-task

Keywords: Agios Pharmaceuticals Inc, Cambridge , Senior Manager/Associate Director, Case Management Oversight/Medical Review Lead, Executive , Cambridge, Massachusetts