Manager's note - "We would like someone who can perform the duties at the Biostatistician base level without requiring an Epidemiologist or doctor." Title - Drug Safety Analyst, Global Pharmacovigilance Number of Leased Workers needed - 1 Tentative end date - 12 months Work shift (days / times) - 1st shift Work Location - 100% remote Travel Required (% of travel) - No Is this a temp to perm position - pure contract Drug Safety Analyst, Global Pharmacovigilance Join our dynamic Drug Safety & Risk Management team at Client Healthcare, where we are dedicated to ensuring the safety of our products and the well-being of patients worldwide. As a Drug Safety (DS) Analyst, you will support pharmacovigilance tasks and prepare regulatory and internal documents with precision and compliance. This work helps 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 risk management. Key Responsibilities : Perform adverse reaction trending: identify patterns and trends in adverse drug reactions (ADRs) over time to detect emerging safety signals. Contribute to signal detection: use statistical methods to detect potential safety issues from spontaneous reporting databases. Graphical representation: create visual summaries such as line graphs or heat maps to illustrate ADR trends. Safety reports: prepare detailed safety reports including ADR trend analysis and frequencies for regulatory submissions. Risk-benefit analysis: support assessments of the overall safety profile of drugs considering observed adverse events. Required Qualifications : Degree in Statistics or Biostatistics: bachelor's or master's degree in relevant field. Analytical skills: knowledge of signal detection methods like disproportionality analysis and Bayesian approaches; trend analysis skills. Data management: experience managing large datasets and using pharmacovigilance-specific databases. Report writing: ability to produce clear and concise safety reports. Collaboration: effective teamwork with clinical research, regulatory, and medical teams. Pharmacovigilance training or certification: highly beneficial. Regulatory knowledge: understanding of drug safety reporting guidelines (e.g., FDA, EMA). Desired Characteristics : High accuracy, attention to detail, quality-focused. Independent, proactive, with strong initiative. Why Join Us : Professional growth: opportunities for learning and advancement. Impactful work: contribute to global patient safety and well-being. #J-18808-Ljbffr BayOne
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