# Safety & PV Specialist I

**Company**: Syneos Health
**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_25104372?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_30a28e52-9f5

## Description

Syneos Health is seeking a Safety & PV Specialist I to join their team. The successful candidate will be responsible for ensuring the quality and timeliness of safety reporting, as well as maintaining compliance with regulatory requirements.

**Job Responsibilities**

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

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

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

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

- Compile complete narrative summaries

- Identify information to be queried and follow up until information is obtained and queries are satisfactorily resolved

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

- Maintain safety tracking for assigned activities

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

- Validate and submit xEVMPD product records

- Participate in audits as required

**Qualifications**

- Bachelor's degree in life science, registered nurse, pharmacist, or an 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 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

**Benefits**

- Career development and progression opportunities

- Supportive and engaged line management

- Technical and therapeutic area training

- Peer recognition and total rewards program

- Total Self culture allowing authentic self-expression

- Diversity of thoughts, backgrounds, cultures, and perspectives

## Skills

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

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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_25104372?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)