Senior Clinical Trial Safety Scientist (Permanent Home Based)
Senior Clinical Trial Safety Scientist (Permanent Home Based)
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Job Description
Responsibilities
Ensure consistent processes and efficient review of critical clinical/safety data
Review of patientlevel 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 startup 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 highlevel 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 nondrug 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 crossfunctionally 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 .
At IQVIA we believe that diversity inclusion and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone everywhere. When our talented employees bring their authentic selves and their diverse experiences to work they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multitalented collaboration harnesses innovation to deliver superior outcomes.
Required Experience:
Senior IC
Employment Type
Full-Time
