Clinical Safety Specialist

3 dni temu

Warszawa, Mazovia, Polska IQVIA LLC Pełny etat
Job Description
Clinical Trial Safety Scientist:
  Key Responsibilities
  
  1. Ensure consistent processes and efficient review of critical clinical/safety data.
  2. Review patient-level clinical/safety data on an ongoing basis to ensure medical accuracy and completeness, coding consistency, and generate applicable queries as needed for appropriate medical assessment and case closure.
  3. Prepare aggregated data visualization and facilitate meetings related to the review of safety data on a study level.
  4. Contribute to study start-up activities according to the applicable processes/procedures (e.g., input to applicable documents, tools setup).
  5. Serve as a member of the Extended Study Team and report on TRISARC deliverables.
  6. Work with study physicians and/or clinical/project scientists to support standardized high-level data review and medical evaluation.
  7. Escalate urgent and critical medical cases to the study physician/medical scientist as appropriate.
  8. Provide input into the process of setting automated patient narratives, if applicable.
  9. Provide input to establishing the process for handwritten patient narratives, including guideline development and the quality control process if applicable.
  10. Lead quality of own deliverables.
  11. Take on tasks as assigned by the Directors, Associate Directors Clinical Trial Safety.

Requirements
  To be successful in this role, you will need:
  
  1. Educational degree (BSc/MSc/PhD) in Life Science or equivalent work experience in directly related fields (preferably medicine, pharmacy, veterinary, biotechnology, nursing, dentistry).
  2. Experience using data review tools such as JReview, JMP Clinical, or Spotfire, EDC.
  3. Understanding of the clinical study and drug development process.
  4. Knowledge of ICH/GCP Guidelines.
  5. Knowledge of SAE reporting requirements.
  6. Quality focus, analytical skills, and ability to concisely summarize large amounts of complex information.
  7. Proven ability to prioritize and manage multiple tasks with conflicting deadlines.
  8. Excellent time management.
  9. Very good interpersonal and communication skills.
  10. Team player, able to work individually.
  11. Ability and willingness to work cross-functionally, e.g., with internal and external partners, on global studies, across different phases of drug development or different therapy areas.

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