Safety Evaluation Scientist-Literature

Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Relevant Years of experience 3 to 6 years. Perform PV literature surveillance assessment activities according to regulations and agreed processes. Timely production of key deliverables including but not limited to: - Screen and review literature search results (articles/abstracts/citations) for aggregate report inclusion and potential safety signal identification. - Maintain and document up-to-date product knowledge for literature evaluation. Participate in quality or continuous process improvement activities related to area of responsibility Discusses need for, and priority of safety related findings/ signal reviews with the SERM product specialists / SERM physician, communicate, escalate, and document the outcome of signal detection process. Analyse and discuss safety data results with the SERM product specialists/ SERM physician and other key stakeholders Know where to find relevant safety information on products. Familiar with aggregate reports (DSURs, PBRERs), Risk management activities (RMPs), labelling documents (GDS, DCSI) Demonstrate GSK values Job Related Experience: Pharmaceutical industry experience (e.g., drug safety (desired), regulatory, clinical development, medical affairs) Basic knowledge of post-marketing regulations applicable to drugs. Knowledge of the principles of causality assessment and the evaluation of safety signals. Service-oriented attitude and ability to be a team player and interact effectively with all levels of personnel in an interdisciplinary and matrix environment. Working knowledge of key pharmacovigilance regulations and methodologies Basic knowledge of medical and drug terminology. Basic understanding of therapy areas of assigned products. Basic knowledge of some other relevant disciplines (e.g. statistics, pharmacoepidemiology). Experience in scientific literature review, data gathering, data synthesis, analysis and interpretation. Knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities. Excellent English language skills - written and verbal particularly in scientific/medical terminology Ability to evaluate data and draw conclusions independently High attention to detail. Highly developed interpersonal, presentation and communication skills. Computer proficiency, IT skills, the expertise and ability to work with web-based applications High level of flexibility and ability to prioritize work