# Safety & PV Specialist I

**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_25104365?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_9c76e3fd-8bc

## 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, processing and evaluating Individual Case Safety Reports (ICSRs), and maintaining safety tracking for assigned activities.

Key responsibilities include:

- Entering information into PVG quality and tracking systems for receipt and tracking ICSRs

- Evaluating ICSR data for completeness, accuracy, and regulatory reportability

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

- Compiling complete narrative summaries

- Identifying information to be queried and following up until information is obtained and queries are satisfactorily resolved

- Assisting in the generation of timely, consistent, and accurate reporting of expedited reports

- Maintaining safety tracking for assigned activities

- Performing literature screening and review for safety, drug coding, and maintenance of drug dictionary

- Validating and submitting xEVMPD product records

- Managing duplicate ICSRs and performing quality reviews

- Ensuring compliance with SOPs, WIs, global regulations, GCP, ICH guidelines, and GVP

- Fostering constructive working relationships with project team members

- Participating in audits as required

The ideal candidate will have:

- A Bachelor's degree in life sciences, nursing, pharmacy, or an equivalent combination of education and experience

- Knowledge of safety database systems and medical terminology

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

- Proficiency in Microsoft Office Suite, Visio, and internet applications

- Excellent communication and interpersonal skills

- Strong organizational skills with attention to detail and ability to prioritize tasks

Syneos Health offers a range of benefits, including career development opportunities, supportive line management, technical and therapeutic area training, and a total rewards program.

## Skills

### Required
- life sciences
- nursing
- pharmacy
- safety database systems
- medical terminology
- clinical trial processes
- GCP
- ICH guidelines
- GVP
- Microsoft Office Suite
- Visio

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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_25104365?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)