Clinical Trial Safety Scientist (Permanent Home Based)

IQVIA LLC; Warszawa; On-site; PLN 81,000 - 273,000; Full time

Job summary

IQVIA is a global leader in clinical research services and healthcare analytics. We are seeking a Pharmacovigilance/Drug Safety professional to review critical clinical data, ensure medical accuracy, and support safety evaluations across studies.

The role involves data visualization, study start-up input, and cross-functional collaboration with study physicians and scientists. Candidates should have a Life Science degree and at least 2 years in pharmacovigilance or drug safety, with knowledge of

Qualifications

• Educational degree (BSc/MSc/PhD) in Life Science or equivalent work experience in related fields.
• Minimum 2+ years of Pharmacovigilance / Drug Safety experience.
• 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.

Responsibilities

• Ensure consistent processes and efficient review of critical clinical/safety data.
• Review patient-level clinical/safety data to ensure medical accuracy and generate applicable queries.
• Prepare aggregated data visualization and facilitate study-level safety reviews.
• Contribute to study start-up activities per applicable processes and tools.
• Serve as a member of the Extended Study Team and report on TRISARC deliverables.
• Support standardized high-level data review and medical evaluation with study physicians/scientists.
• Escalate urgent medical cases to the study physician/medical scientist as needed.
• Provide input into automated and handwritten patient narratives processes as applicable.
• Lead quality of own deliverables and contribute to procedural improvements.

Skills

Pharmacovigilance

Drug Safety

Data review

Cross-functional collaboration

Time management

Education

BSc/MSc/PhD in Life Science

Tools

Data review tools

Job description

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 2+ 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 https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. The potential base pay range for this role, when annualized, is zł80,500.00 - zł272,500.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.