# Clinical Safety Data Reviewer

**Company**: IQVIA
**Location**: Warsaw, Poland
**Experience**: senior
**Job type**: full-time
**Salary**: zł83,000.00 - zł196,600.00
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Warsaw-Poland/Clinical-Trial-Safety-Scientist--Permanent-Home-Based-_R1575483?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/clinical-safety-data-reviewer-80dc7766-0fd/

## Description

We are seeking a Clinical Safety Data Reviewer to join our team in Warsaw, Poland. You will play a crucial role in ensuring the accuracy and completeness of clinical/safety data for our clients.

**Responsibilities**

- Review patient-level clinical/safety data to ensure medical accuracy and completeness, coding consistency, and generate applicable queries as needed

- 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

- Serve as a member of the Extended Study Team and report on TRISARC deliverables

- Work with 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

**Requirements**

- 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

**What We Offer**

- The potential base pay range for this role, when annualized, is zł83,000.00 - zł196,600.00

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## Skills

### Required
- Life Science
- Pharmacovigilance
- Drug Safety
- ICH/GCP Guidelines
- SAE reporting

### Nice to have
- data review tools

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Warsaw-Poland/Clinical-Trial-Safety-Scientist--Permanent-Home-Based-_R1575483?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)
