Talascend is seeking an experience Statistician ( Drug Safety Analyst) , for a Fully-Remote opportunity. This is a long-term contract opportunity with benefits. You will support pharmacovigilance tasks and prepare regulatory and internal documents with precision and compliance. These tasks help ensure that potential safety issues are identified and addressed promptly, contributing to the overall safety and efficacy of pharmaceutical products. Your work will support product safety signal detection and product safety risk management. Key Responsibilities : Adverse Reaction Trending : Identify patterns and trends in adverse drug reactions (ADRs) over time to detect emerging safety signals. Signal Detection : Use statistical methods to detect signals of potential safety issues from spontaneous reporting databases. Graphical Representation : Create visual summaries such as line graphs or heat maps to illustrate trends in ADRs. Safety Reports : Prepare detailed safety reports analyzing ADR trends and frequencies for submission to regulatory authorities. Risk-Benefit Analysis : Support risk-benefit analyses to assess the overall safety profile of a drug in light of observed adverse events. Required Qualifications : Degree in Statistics or Biostatistics : A bachelor's or master's degree in statistics, biostatistics, or a related field is essential. Analytical Skills : Knowledge of various signal detection methods such as disproportionality analysis and Bayesian approaches. Ability to perform trend analysis and identify patterns in ADR data. Data Management : Skills in managing large datasets and using databases specific to pharmacovigilance. Report Writing : Strong skills in writing clear and concise safety reports. Collaboration : Ability to work effectively with cross-functional teams, including clinical research, regulatory affairs, and medical affairs. Pharmacovigilance Training : Specialized training or certification in pharmacovigilance can be highly beneficial. Regulatory Knowledge : Understanding of regulatory requirements and guidelines for drug safety reporting (e.g., FDA, EMA guidelines). High level of accuracy, attention to detail, and quality in all tasks. #J-18808-Ljbffr Talascend
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