Purpose:
• To coordinate and prepare key ASRs for Celgene‘s development and marketed products
• To support the assessment, communication & actions pertaining to ASRs
Key Activities
Aggregate safety report (ASR) preparation
• Support and/or primary role responsible for creation and/or support creation of ASRs (PSURs, US PSRs, DSURs and RMP Updates)
• Write / draft appropriate sections of each of the documents
• Coordination and preparation of ASRs
• Ensure synchronization among ASRs as necessary
• Contribute to coordination of report process including compilation of information from other functional areas
• Collaborate with other members of the ASR group to ensure all activities are completed
• Obtain, coordinate & collate exposure data
• Ensure full review of ASRs
• Update/edit ASRs during review cycle
• Respond to comments from contributors as appropriate
• Develop further evaluation & analysis as needed
• Contribute to the identification of search criteria for Risks, Events of Interest
• Contribute to report process development and refinement
• Contribute to identifying user requirements for reports
• Work with informatics to ensure appropriateness of output from BO & other system applications
• Collaborate on the drafting of key SOPs & WPs related to report processes
• Contribute to establishment or updates to conventions & templates
• Support other GDSRM activities regarding ASRs
• Perform other activities as needs arise in the context of aggregate safety information
Issues management
• Contribute to the elevation of potential issues for management
• Facilitate determination of nature of issue
• Ensure follow-up and/or internal notification
Outputs
• PSURs, US PSRs, DSURs
• Meeting agendas, slide decks, minutes, action items
• SOPs/WPs
Context &Responsibilities:
• Manage and/or support management of key regulatory periodic reports for development and marketed products, under the direction of Senior Manager, ASR
• Analyzing data & drafting documents / sections of documents required for assessment & communication of product safety information, under the direction of Senior Manager, ASR
• Liaising with PV/EPI group supporting approved products and activities
• Liaising with TSS group supporting development products and activities
• Liaising with Regulatory Affairs to coordinate synchronization of periodic reports
• Drafting key SOPs/WPs/templates
Knowledge:
• Knowledge of clinical trials & drug development
• Knowledge of interpretation & presentation of aggregate safety data
• Knowledge of signal recognition & statistical techniques
• Knowledge of statistical analysis
• Appreciation of commercial drug environment
• Clinical knowledge of therapeutic area patient populations & drug classes
• Understanding of safety data capture in CT & PM settings
• Appreciation of the global safety environment, international regulations & guidance documents
• Knowledge/understanding of document approval/storage databases, e.g., eSub Livelink
• Scientific/medical writing experience preferred
• Knowledge of US, EU and ROW Compliance / Regulatory regulations
Competencies:
• Attention to detail
• Critical thinking
• Organization and planning
• Excellent communication skills (written & oral)
• Ability to interpret, analyze and clearly present scientific & technical data (oral & written)
• Strong analytic skills
• Scientific /medical writing
• Team work on a global multifunctional team
• Information analysis
• Ability to work with minimal supervision
• Ability to thrive in a global matrix environment
• Ability to make decisions
• Sense of urgency
Qualifications
Qualifications:
• Minimum of BA/BS/PharmD degree in Life sciences, Clinical sciences
• RN or BS/PharmD preferred
Experience:
• Five (5) years relevant experience in pharma/biotech, preferably in PV
• Three (3) years experience medical writing, preferably in ASRs
• Experience with safety databases (ARISg or similar) and their output