Clinical Pharmacokineticist (FSP Permanent Homebased)
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Job Location:
Monthly Salary:
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Job Summary
Key Responsibilities
- Ensure all PK/PD deliverables are inspection-ready and compliant with relevant requirements and internal guidelines.
- Maintain central planning for population PK/PD document writing and QC deliverables.
- Provide recommendations for process improvements to enhance interactions between CPP and document service management teams.
- Drive PK/PD document shell creation QC processes and timeline management.
- Receive and review documents (e.g. reports) compile comments and edits and follow up on comment resolution in close collaboration with stakeholders.
- Perform QC of PK/PD reports manage review cycles and document findings within QC checklists ensuring timely resolution of comments.
- Support development of CPP reporting templates analysis plans and data transfer plans in partnership with document service management.
- Draft and review protocols PK/PD statistical analysis plans TLFs/TLF shells and clinical study reports.
- Conduct Non-Compartmental Analysis (NCA) using Phoenix WinNonlin 8.3.
- Draft and review programming specifications for PK/PD studies.
Skills & Experience
- Proficient in using Word templates and document formatting.
- Strong experience in scientific report writing and document QC procedures.
- Solid project management and organizational skills; ability to prioritize multiple projects effectively.
- Excellent communication skills (oral and written) in English.
- Experience in population PK/PD report writing and review.
- Familiarity with PK/PD analysis tools and processes including Phoenix WinNonlin.
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
Key Skills
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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
