Position Type : Contract
Experience Level :
Start Date / End Date : 02/04/2013 / 06/29/2014
Job Title: Clinical-Scientific, Quality Assurance
JobTitle Description: Ideal candidate MUST have 2+ yrs of Drug Safety experience with ARGUS Safety Database experience. Healthcare professionals required but MD's would be overqualified. Role Overview: Conducts QC activities on Individual Case Safety Reports (ICSRs) ensuring accuracy, internal consistency, and compliance with SOPs, SJAs/WI, Argus Reference Guide (AURG), and regulatory guidance. Responsibilities: Provides ongoing analysis of data resulting from the quality review of regulator ICSRs/aggregate reports produced by PSSR Supports/promotes accuracy, internal consistency, and compliance with Pharmaceutical guidance documents and regulatory expectations Knowledge of global regulatory requirements relative to pharmacovigilance, regulatory submission requirements, electronic reporting requirements and other relevant regulatory requirements and guidances Provides support for regulatory inspections, internal audits and/or strategic quality initiatives Develops and maintains an understanding of ARGUS, Pfast, and case processing activities so as ensure the accuracy of ICSRs, aggregate reports, ad hoc reports and analyses Compiles and analyzes ICSR data quality metrics on a routine basis to ensure consistency within cases and correctness of the data relative to the ARGUS Users Reference Guide (AURG), Safety Job Aids (SJAs), and regulatory expectations Participates in quality activities, setting the standard for enhanced collaboration, delivery of project commitments and customer satisfaction Participates independently, as appropriate, in the ongoing review of processes related to the collection and analysis of safety information within PSSR May serve as a subject matter expert working with PSSR on training, knowledge sharing, technology, or specific work processes, providing advice and guidance as appropriate Qualifications: BS or PharmD degree (or equivalent). Pharmacy or Nursing degree is preferred. Minimum of 3 years experience in clinical, safety and/or regulatory areas in the pharmaceutical/healthcare industry. Experience with the Argus Safety Database is preferred. Experience in quality control and/or quality assurance within the pharmaceutical industry preferred. Knowledge of global safety regulations and guidelines, or equivalent. Demonstrated strength in analytical skills and attention to detail. Demonstrated strength in oral/written communication and interpersonal skills. Demonstrated organizational/project management skills. Ability to make decisions independently and resolve issues appropriately. Demonstrated computer literacy, particularly in the use and management of relational databases. TECHNICAL COMPETENCIES: Demonstrated ability to understand and consider competitive positioning when solving problems and making decisions. Demonstrated knowledge of clinical research and development processes, safety or regulatory requirements. Applies technical and line knowledge of key concepts in own discipline and may act as a key technical resource within the line. Knowledge of organizational development principles and demonstrated success in developing and implementing organizational development strategies. Demonstrated ability to manage complex projects and cross-functional processes and to meet established deadlines. Strong platform skills evident. Demonstrated ability to effectively work on simultaneous complex projects/deliverables. Demonstrated analytical and statistical skills. Thorough understanding of system technologies that support the business. BEHAVIORAL COMPETENCIES: Considers stakeholders, including regulatory agencies and safety, in developing strategies and future directions. Has extensive knowledge of the principles, concepts, and theories of the discipline, and working knowledge of principles and concepts of other disciplines. Embraces creativity, supports and takes well conceived risks and pursues new opportunities.
A10 - 10 months ago