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Safety Scientist

  • Location: Lawrenceville, Mercer, New Jersey
  • Job Type:Contract

Posted 22 days ago

  • Expiry Date: 01 August 2021

​​Job Description:

Contact:

  • EDUCATION PREFERRED: : B.S.N./RN, B.A./B.S./M.S. (Life Sciences); B.S. Pharm./R.Ph./Pharm.D. or equivalent.
    YEARS OF EXPERIENCE PREFERRED: 4 years experience in a clinical development setting or 2-3 years Safety experience within the pharmaceutical industry.
    LIST MAJOR SKILLS REQUIRED:
    Experience writing narratives for study drug safety reports.
    Experience using a drug safety database to capture adverse events.
    Experience applying medical knowledge in a business context.
    Experience working in a post-marketing safety or clinical trial setting (i.e., CRO, pharmaceutical company and academic setting).
    Experience working in teams, including supporting other team members when necessary.
    Strong teamwork (with ability to lead a team) and prioritization skills to ensure that processes, procedures and best practices are consistent across GPV&E and that Regulatory requirements are met in a timely manner with high quality.
    Ability to make constructive recommendations to improve processes.
    Demonstrates the ability to multi-task, and flexibility to meet changing business priorities.
    Maintains an in-depth knowledge of the ARGUS Safety Database and Clinical Databases such as RAVE/Trial Access Online etc, and is able to query the systems to support the SUSAR/ESR scientist role.
    Ability to collaborate within multi-disciplinary team on drug safety-related issues including informing safety physicians and scientists within the therapeutic area on case-related issues.
    Ability to apply sound analytical thinking and database query skills to gather, review, summarize and evaluate critical information in a timely manner.
    Strong knowledge of SUSAR process, SOPs, conventions and health authority regulations worldwide, to ensure all safety information is accurate, integrated and current, and is submitted within regulatory timelines.
    Utilizes medical, scientific and clinical knowledge in reviewing safety-related documents (e.g. protocols, investigator brochures, product labels, relevant source documents) and incorporating key concepts to clearly present the reported events, and in turn, maintain patient safety.
    Possess medical writing skills to produce accurate, concise, medically sound expedited reports.
    LIST RESPONSIBILITIES REQUIRED:
    Ability to support GPV&E Vision and Mission through an understanding of the impact and implications of daily work on all customers of the Expedited Safety Report Group.
    Medical and pharmaceutical knowledge (i.e., scientific understanding of the human body and its functions).
    Knowledge and understanding of Health Authority Regulations worldwide, how to access them and when to refer to them.
    High level of knowledge and experience using ARGUS, MedDRA, and RAVE/Trial Access Online/J-Review.
    In depth Knowledge of computer applications and project planning skills.
    Mastery of GPV&E and R&D SOPs, drug safety coding conventions, and work.
    Provide technical support to GPV&E medical review safety physicians (MRSP) including review and interpretation of source documents.
    Participate in the evaluation of serious adverse event reports from spontaneous reports, clinical trials, non-clinical reports and scientific literature.
    Identify additional information required from investigators and collaborate with MRSP to prepare queries to obtain additional information.
    Utilize ARGUS database and J-Review to prepare contextual summaries for expedited safety reports.
    Review and comment on documents and line listings from GPV&E, other departments, and other drug development/marketing partners and contractors.
    Ad Hoc member of Medical Surveillance Team.
    Perform Analysis of Similar Events for potential DILI and events of special interest.
    Serve as a resource for GPV&E information and help develop and participate in and/or lead teams involved with developing or revising GPV&E SOPs.

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