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Safety Specialist II

INC Research

Warsaw, Poland

Core responsibilities:

  • Interfaces between Company, sponsors, vendors, and other departments in the area of safety and pharmacovigilance;
  • Assists in the design and implementation of safety collection, processing, and reporting systems; acts as a primary point of contact for information regarding assigned projects;
  • Represents Safety and Pharmacovigilance on cross functional teams;
  • Assists with the workload of other Safety Specialists within the department;
  • Liaises with Manager or designee with regard to resources, timelines, and issues with quality;
  • Reorganizes daily workload based on priority; proactively communicates to management new issues; offers solutions and reports availability to take on new assignments;
  • Trains new staff; acts as the primary resource for other Safety Specialists with regards to answering questions, sharing knowledge and assisting in resolving problems; provides technical support;
  • Mentors less experienced members of the team;
  • Assumes responsibilities of safety project leader/endpoint manager for projects which require a team of Safety Specialists, including but not limited to:
    • Assignment of resources and timelines; reorganization of daily workload based on priority;
    • Decision making for the project;
    • Proactive communication to management new issues and suggested solutions; and reporting availability to take on new assignments;
    • Development and review of project proposals, budgets, agreements, invoices, financial measures, and performance metrics;
    • Preparation of a Safety Management Plan;
    • Coordination of workload/workflow and coordination of status reviews;
    • Review of project performance metrics (including quality parameters, monthly budget reports, and changes in scope);
    • Approval of invoices.
  • Manages systems for receipt and tracking adverse event (AE)/endpoint information;
  • Processes AEs/endpoints according to Standard Operating Procedures (SOPs), and project specific safety plan;
  • Ensures that all aspects of the Company’s safety data collection and processing are consistent with current industry practices and meet all pertinent domestic and international regulatory requirements; ensures correct study setup and closure including proper documentation and archival;
  • Trains Investigators and other departments on AE reporting/adjudication;
  • Delivers presentations regarding safety and pharmacovigilance to internal and external customers;
  • Provides support to senior departmental management surrounding business development activities, budget, and proposal input, etc., as required;
  • Maintains current professional knowledge in fields of safety management, coding, computer science, quality assurance, regulatory affairs, and applicable areas of medical sciences to serve as a basis for providing “value added” expanded company services to all appropriate clients;
  • Provides input to senior departmental management regarding ways to ensure adherence to relevant procedures/regulations, ways to improve work efficiency and maintain customer satisfaction;
  • Maintains understanding of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process;
  • Maintains knowledge of ongoing projects and disease-related terminology.

Skills and attributes:

  • BA/BS in Life Science or Registered Nurse/Pharmacist;
  • Moderate experience in Safety and Pharmacovigilance or clinical/clinical research experience or equivalent combination of education and experience. Clinical Research Organization (CRO) experience with therapeutic specialties preferred;
  • Knowledge of relevant international regulations/guidelines and strong understanding and usage of medical terminology preferred;
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), e-mail, and internet;
  • Strong organizational, presentation, documentation, analytical, oral/ written (English), and interpersonal skills with strong judgment and tactful discretion appropriate to a professional medical setting;
  • Ability to make effective decisions, manage multiple priorities, exhibit high degree of accuracy, and meet deadlines in a highly dynamic environment;
  • Ability to be flexible, adapt to change, work independently, as well as part of a team in a matrix environment.

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