Job Description

Provide support for Central Safety Department (CSD) literature screening activities for both ICSR and signal detection purposes in accordance with their procedures and regulatory requirements Support SERM product specialists by identifying articles of interest for relevant safety information from screened publications for all of GSKs product portfolio Perform PV literature surveillance activities according to appropriate regulations and agreed processes Ensure timely production of key deliverables including but not limited to: o Screening and review of literature search results (articles/abstracts/citations) for purposes of ICSR identification o Triaging literature search results for potential articles of interest with relevant safety information concerning both GSK marketed and GSK products in development, for signal detection/periodic reporting purposes using defined algorithms and criteria o Maintaining and documenting up-to-date product knowledge to aid in literature review o Possess good knowledge of the maintenance of product knowledge and Master drug list o Demonstrate proficiency in quality checks for literature articles triaged by junior team members Develop and share pharmacovigilance and literature surveillance knowledge and experience with team members Recognizing potential issues and interacting with team members to resolve issues Participate in quality or continuous process improvement activities related to area of responsibility as required Mentoring and training new team members on literature review process as required Competencies: 7 to 11 years of relevant industry experience Pharmaceutical industry experience (eg drug safety (desired), regulatory, clinical development, medical affairs) Working knowledge of key pharmacovigilance regulations and methodologies Good 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 Service-oriented attitude and ability to be a team player and interact effectively with all levels of personnel in an interdisciplinary and matrix environment Ability to implement new processes and quality initiatives Computer proficiency, IT skills, the expertise and ability to work with web-based applications High level of flexibility and ability to prioritize work

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