Alexion Pharmaceuticals Case Management Specialist in Boston, Massachusetts
The Case Management Specialist, Global Drug Safety Operations is accountable for the execution of Alexion’s Individual Case Safety Reports (ICSR) case processing and vendor interaction and oversight. This position contributes to the development, documentation, implementation and maintenance of the processes and standards required to ensure Alexion maintains compliance with ICSR processing and reporting. The position will liaise with groups both internal and external to Drug Safety regarding activities associated with case processing including but not limited to Development Operations, Regulatory Affairs, Global Clinical Operations , and Global Operations Quality. The Global Drug Safety Case Management Specialist to the Director and/or Associate Director Global Drug Safety Case Management..
Job Duties & Responsibilities
Primarily responsible for the creation, oversight, and continuous improvement of adverse event case management globally. Liaises with staff in GDS functions as appropriate to facilitate compliant, timely and efficient case handling for adverse event reports from spontaneous, clinical, and literature sources.
Responsibilities for this role include, but are not limited to:
Monitors and manages case workflow in Argus Safety
Support business continuity activities as needed
Participate and support in GDS System user acceptance testing for Safety database upgrades, enhancements, and bug fixes.
Organizing and leading routine Case Management meetings to ensure consistent and compliant case handling practices
Assesses ICSRs (ADRs) for completeness and accuracy
Performs quality assurance checks on cases within Argus workflow and retrospectively post case processing.
Documents and forwards ADEs and ADRs to Safety vendor for processing
Performs reconciliation activities of ICSRs with internal Alexion and non Alexion business partners.
Ensures upload of all supporting case documentation within the Global safety Database if necessary
Downloads ICSRs from the Eudravigilance Safety Database
Performs Literature review activities as required for regulatory reporting
Archives documents in BOX, SharePoint, and other document repositories.
Partners with case processing safety vendor to ensure timely transfer and processing of cases.
Produces and updates Standard Operating Procedures (SOPs), guidance documents, and standards for global case intake
Supports internal audits and health authority inspections, often outside normal business hours.
Assumes other responsibilities as requested to support Regulatory Compliance activities.
Assists the Director and Associate Director of, Global Drug Safety case Management in planning future case management strategy
Working knowledge of drug safety reporting procedures both domestic and international regulatory requirements, two years of drug safety experience preferred.
Medical terminology and drug knowledge
Strong process management, communication skills and organizational skills
Ability to review, analyze, interpret and manage complex data to a high standard
Good level of computer literacy and knowledge of archiving of large amounts of data
Good navigating knowledge of Microsoft applications including SharePoint and Outlook
Working knowledge of computer databases and spreadsheet applications (e.g., Microsoft Access and Excel), including the ability to produce pivot tables and graphs
Working knowledge of PowerPoint and other presentation design applications
Excellent organization skills and ability to prioritize
Highly organized and demonstrates understanding of workflow prioritization
Technical system skills (e.g., data processing and data entry knowledge)
Able to manage own work, multi-task, plan and organize work assignments and work under timelines
Ability to work under strict deadlines and changing priorities with minimal supervision
- Natural Sciences degree preferred or minimum 4 years of pharmaceutical experience
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.
Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.