Clinical Trial Safety Scientist (Permanent Home Based)
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Job Location:
Monthly Salary:
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
Responsibilities
Ensure consistent processes and efficient review of critical clinical/safety data
Review of patient-level clinical/safety data on an ongoing basis to ensure medical accuracy and completeness coding consistency and generate applicable queries as needed to obtain information for appropriate medical assessment and case closure
Prepare aggregated data visualization and facilitate meetings related to review of safety data on study level
Contribute to study start-up activities according to the applicable process/procedures (ex. input to the applicable documents tools set up)
Serve as a member of the Extended Study Team and report on TRISARC deliverables
Work with the study physicians and/or clinical/project scientists to support standardized high-level data review and medical evaluation
Escalate urgent and critical medical cases to the study physician/medical scientist as appropriate
Provide input into the process of setting automated patient narratives if applicable
Provide input to establishing the process for handwritten patient narratives including guideline development and the quality control process if applicable
Lead quality of own deliverables
Take on tasks as assigned by the Directors Associate Directors Clinical Trial Safety
Provide input into non-drug project work including training activities continuous improvement and development of procedures as needed
Education/Experience
Educational degree (BSc/Msc/PhD) in Life Science or equivalent work experience in directly related fields
Minimum 4 years of experience in Pharmacovigilance / Drug Safety
Understanding of the clinical study and drug development process
Knowledge of ICH/GCP Guidelines
Knowledge of SAE reporting requirements
Experience using data review tools is preferred
Quality focus analytical skills and ability to concisely summarize large amounts of complex information
Proven ability to prioritize and manage multiple tasks with conflicting deadlines
Excellent time management
Very good interpersonal and communication skills
Team player able to work individually
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
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
Required Experience:
IC
Key Skills
- Laboratory Experience
- Immunoassays
- Machine Learning
- Biochemistry
- Assays
- Research Experience
- Spectroscopy
- Research & Development
- cGMP
- Cell Culture
- Molecular Biology
- Data Analysis Skills
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more
