Alexion Pharmaceuticals Drug Safety Intake Associate III in Boston, Massachusetts
The Associate III, Global Drug Safety Intake is accountable for the execution of Alexion’s Individual Case Safety Reports (ICSR) intake. This position contributes to the development, documentation, implementation and maintenance of the processes and standards required to ensure Alexion maintains compliance with ICSR intake. The position will liaise with groups both internal and external to Drug Safety regarding activities associated with case intake including but not limited to Development Operations and Quantitative Science, Regulatory Affairs, Global Operations Quality. The Global Drug Safety Intake Associate III reports to the Director, Global Drug Safety Intake, Policy & Vendor/Alliance Management.
Job Duties & Responsibilities
Primarily responsible for the creation and continuous improvement of adverse event intake globally. Liaises with staff in GDS functions as appropriate to facilitate compliant, timely and efficient inbound case receipt, registry and/or literature surveillance processes.
Responsibilities for this role include, but are not limited to:
Monitors the Clinical Serious Adverse Events (SAEs) and Post-Marketing mailboxes for incoming Inidividual Case Safety Reports (ICSRs)
Assesses and triages the reportable Adverse Drug Event (ADEs) and Adverse Drug Reactions (ADRs) for completeness and ensures they are legible for processing
Orgnaizes the incoming ADE and ADR data originating from post-marketing sources, clinical trials, literature and other sources
Documents and forwards ADEs and ADRs to Safety vendor for processing
Performs reconciliation of the ADEs and ADRs receipt with vendor sites, safety CROs, Local Safety Officers (LSOs) and Alexion affiliates
Ensures upload of all incoming E2B reports from Safety Gateway to ARGUS
Downloads ICSRs from the Eudravigilance Safety Database
Archives ADEs and ADRs in the SharePoint repository, and creates, organizes and maintains folder on SharePoint site for ADEs and ADRs
Partners with case processing safety vendor to ensure timely transfer of cases
Produces and updates Standard Operating Procedures (SOPs), guidance documents, and standards for global case intake
Assumes other responsibilities as requested
Assists the Director of, Global Drug Safety Intake, Policy & Vendor/Alliance Management in planning future case intake strategy
Working knowledge of drug safety reporting procedures both domestic and international regulatory requirements
Medical terminology and drug knowledge is preferred
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 multinational biopharmaceutical company with approximately 2,500 dedicated employees serving patients in more than 50 countries through the innovation, development, and commercialization of life-changing therapies. As the global leader in complement biology, Alexion 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). In addition, Alexion 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). Our research efforts focus on novel molecules and targets in the complement cascade, and our development efforts focus on our core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders.
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.
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. To learn more about Alexion, please visit www.alexion.com.
Alexion is an Equal Opportunity /Affirmative action employer