# Safety & PV Specialist I - Remote, China

**Company**: Syneos Health
**Work arrangement**: remote
**Experience**: entry
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/CHN-Remote/Safety---PV-Specialist-I_25104368?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_305293eb-218

## Description

Syneos Health is seeking a Safety & PV Specialist I to work remotely in China. The successful candidate will be responsible for ensuring compliance with safety and pharmacovigilance regulations.

**Job Responsibilities**

- Enter information into PVG quality and tracking systems for receipt and tracking of Individual Case Safety Reports (ICSRs)

- Assist in processing ICSRs according to Standard Operating Procedures (SOPs) and project-specific safety plans

- Triage ICSRs, evaluate data for completeness, accuracy, and regulatory reportability

- Code events, medical history, concomitant medications, and tests

- Compile narrative summaries and identify information to be queried

- Assist in generating timely and accurate reporting of expedited reports

- Maintain safety tracking for assigned activities

- Perform literature screening and review for safety, drug coding, and MedDRA coding

- Validate and submit xEVMPD product records

- Identify and manage duplicate ICSRs

- Participate in audits as required

**Qualifications**

- Bachelor's degree in life science, registered nurse, pharmacist, or equivalent combination of education and experience

- Knowledge of safety database systems and medical terminology

- Understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements

- Proficiency in Microsoft Office Suite, Visio, and internet

- Ability to work independently and in a team environment

- Excellent communication and interpersonal skills

- Good organizational skills with proven ability to prioritize and work on multiple tasks and projects

**What We Offer**

- Opportunity to work with a leading biopharmaceutical solutions organization

- Collaborative and dynamic work environment

- Professional development and growth opportunities

## Skills

### Required
- Safety Database systems
- Medical terminology
- Clinical trial process
- ICH GCP
- GVP
- Microsoft Office Suite
- Visio
- Internet

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/CHN-Remote/Safety---PV-Specialist-I_25104368?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)